Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Conditions: Ureter Obstruction
Sponsor: Boston Scientific Corporation

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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
 
DJUS-PLUS Registry 
U0652 
CLINICAL INVESTIGATION PLAN 
 
 
 
Sponsored By 
Boston Scientific Corporation 
 
300 Boston Scientific Way 
Marlborough, MA 01752, United States 
 
 
Boston Scientific International SA 
 
Parc Val Saint-Quentin, Bâtiment H 
2 Rue René Caudron 
78960 Voisins le Bretonneux 
France 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
Debra Jovanovich, MS 
Clinical Project Manager 
Boston Scientific Corporation 
Urology and Pelvic Health 
100 Boston Scientific Way 
Marlborough, MA 01752 
651-706-0271 
Debra.Jovanovich@bsci.com 
 
Coordinating 
Principal 
Investigator(s) 
Amy Krambeck, MD 
Professor of Urology 
Feinberg School of Medicine  
Northwestern University  
676 N. St. Clair St 
Arkes 2300  
Chicago, IL 60611 
Amy.Krambeck@nm.org 
 
Coordinating 
Co-Principal 
Investigator 
Michael Borofsky, MD 
Associate Professor of Urology  
University of Minnesota Medical School 
420 Delaware St. SE MMC 934 
  Minneapolis, MN 55455 
mborofsk@umn.edu  
 
 
 
 

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Original Release: December 3, 2019 
Current Version:  September 15, 2021 
 
Revision 
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Date 
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number 
and version 
Protocol Section 
Modified 
Summary of Changes 
 
Justification for Modification 
Revision 
A (initial) 
December 
3, 2019 
92120219_
Rev/Ver C 
N/A 
N/A 
Initial Release 
Revision 
B 
June 2, 
2020 
92120219_
Rev/Ver C 
Contact Information 
Contact Information: Removed Jennifer 
Saunders. 
 
Contact Information: Updated 
section for accuracy (Clinical 
Contact only). 
Section 2. Protocol 
Synopsis;  
Section 5.1 
Commercial Device;  
Section 7.1 Scale and 
Duration 
Device/System applied as standard of 
care: Removed Double-J Ureteral Stents: 
Ascerta, Mardis Soft, and Stretch VL 
Flexima and modified/added Tria to Tria 
Soft and Tria firm.  
The stents removed are no 
longer in production and 
therefore will not be studied in 
this registry. Tria stents were 
separated to Tria Soft and Tria 
Firm for clarity. 
Section 2. Protocol 
Synopsis;  
Section 7.1 - Figure 
7.1 
Study Design Chart: Modified planned 
indwell time flow chart  
The flow chart was updated for 
clarity. 
Section 2. Protocol 
Synopsis;  
Section 6 – Study 
Objectives and 
Endpoints; Section 
11.3.1.2 Additional 
Endpoint 2 – Ureteral 
Stent Migration 
Stent Migration:  Confirmed via imaging 
Changed to 
Stent Migration:  defined as any post 
procedure movement of the stent (either 
proximally towards the kidney or 
distally towards the bladder or complete 
distal migration) from its implant 
location; confirmed via imaging where 
necessary 
Stent migration definition was 
added to provide clarity. 

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Justification for Modification 
“Note: External force or inadvertently 
pulled stents are not considered Stent 
migration.” 
Section 2. Protocol 
Synopsis; Section 10.6 
– Post procedure 
follow-up 
 
Post-Procedure (if Long term indwell of > 
90 days): ≤ 90 days from Index Procedure  
Changed to 
Post-Procedure Follow-up Visit (if Long 
term indwell of greater than 90 days): ≤ 
90 days from Index Procedure  
Post Procedure language 
modified to clarify the 
requirement. 
 
Section 2. Protocol 
Synopsis; Section 
11.1.1.2 Sample size; 
11.1.1.3 Statistical 
Methods 
Statistical Test Method: Added “Only 
stents placed at least 12 hours will be 
included in the analysis”. 
 
Sample Size Parameters 
Assuming that the Tria™ stent technical 
success rate is 94% for Stone 
Management, a sample size of 127 subjects 
with Tria™  placed for Stone Management 
is required to attain 90% power to 
demonstrate the primary hypothesis at the 
2.5% significance level(one-sided). 
Approximately 142 Stone Management 
subjects with Tria™ stent procedures will 
be required to allow for 10% subject 
attrition 
Changed to  
Assuming that the Tria™ stent technical 
success rate is 94% for Stone 
Management, a sample size of 127 subjects 
with Tria™ placed at least 12 hours for 
Stone Management is required to attain 
Criteria added to determine 
when to include stents in 
analysis. 
 
Language was added to define 
the criteria for stent indwell 
time. 

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90% power to demonstrate the primary 
hypothesis at the 2.5% significance 
level(one-sided). Approximately 142 Stone 
Management subjects with Tria™ stent 
procedures where stents indwell at least 
12 hours will be required to allow for 10% 
subject attrition  
Section 6 Study 
Objectives and 
Endpoints 
Primary efficacy endpoint: Technical 
Success of the stents  
Changed to  
Primary efficacy endpoint: Technical 
Success of the stents defined as Stented 
kidney drains (to bladder) during the 
planned indwell time with no re-
intervention due to obstruction of the 
stented ureters 
Technical success of the stents 
defined to provide clarity. 
 
Table 10.1: Data 
Collection Schedule 
Modified table to reflect changes presented 
in sections below. 
The Screening/Enrollment and 
Baseline requirements have been 
modified to allow for data to be 
captured prior to the index 
procedure 
Section 10.4 Screening 
Assessments/Procedur
es 
 
The Screening/Enrollment may occur prior 
to the Baseline Visit. At this visit, the 
assessments below must be completed 
Changed to 
The Screening/Enrollment and Baseline 
visit may occur on the same day or on 
different days.  The following must be 
completed prior to collecting baseline data 
described in section 10.5  
The Screening/Enrollment and 
Baseline requirements have 
been modified to allow for data 
to be captured prior to the 
index procedure 

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10.5 Baseline Visit 
The assessments below must be completed 
prior to index procedure. This visit may 
be combined with the 
Screening/Enrollment Visit and may 
occur up to 45 calendar days prior to index 
procedure.  
Changed to  
The assessments below must be 
completed prior to index procedure and 
may occur up to 45 calendar days prior 
to index procedure.  
The Screening/Enrollment and 
Baseline requirements have 
been modified to allow for data 
to be captured prior to the 
index procedure.   
10.5 Baseline Visit 
Urinalysis/culture: UTI status, Pregnancy 
test for women of child bearing age (if 
collected as SOC) 
Changed to  
Urinalysis/culture: UTI status, 
Pregnancy test for women of child 
bearing potential 
Pregnancy test is required to 
collect prior to the index 
procedure. 
10.5 Baseline Visit 
Added:  
Physical examination: Height, Weight, 
BMI, Temperature 
QoL Questionnaires (PROMIS):  
• 
Adult Short Form v1.0 – Pain 
Intensity 3a 
Adult Short Form v1.0 – Pain Interference 
6b  
The Baseline visit requirements 
have been modified to allow for 
data to be captured prior to the 
index procedure 
10.6 Index Procedure 
(Double-J Ureteral 
Stent Placement) 
 
Added:  
Note:  Baseline visit information may be 
collected on same day, prior to the index 
procedure” 
Providing further clarification on 
the data collection schedule; 
collecting time of the stent 
placement to determine the 12 

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After the index procedure, the following 
data will be collected: 
Stent Information – type, size, stent 
laterality (left or right), unilateral or 
bilateral 
Changed to 
After the index procedure, the following 
data will be collected: 
• 
Stent Information – type, size, 
stent laterality (left or right), 
unilateral or bilateral, time of 
stent placement 
hour minimum stent placement 
time.  
10.7 Post-procedure 
Follow-up (if Long 
term indwell of > 90 
days) 
Section Header Post-procedure Follow-up 
(if Long term indwell of  > 90 days) – on 
or before 90 days from index procedure 
as indicated in individual stent DFU  
Changed to  
Post-procedure Follow-up (if Long term 
indwell of > 90 days) 
Providing further clarification on 
the post procedure follow-up 
schedule, visit window and when 
is visit not required.  
10.7 Post-procedure 
Follow-up (if Long 
term indwell of > 90 
days) 
Stent indwell time should be per individual 
DFU. The subjects should be followed in 
clinic on or before 90 days from index 
procedure if stent is not explanted and 
planned for a long term indwell. During 
this visit the following data will be 
collected.  
Changed to  
Stent indwell time should be per individual 
IFU/DFU. If indwell of greater than 90 
days is planned, a post-procedure 
follow-up should be completed between 
Providing further clarification on 
the post procedure follow-up 
schedule, visit window and when 
is visit not required.  

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45 - 90 days from index procedure as 
indicated in individual stent IFU/DFU.   
The subjects should be followed in clinic 
for the following data collection.  
Added: If indwell of less than 90 days is 
planned, a post-procedure follow-up is not 
required. 
10.8 Stent Removal 
Visit (maximum 
indwell time as 
indicated in individual 
stent IFU/DFU) 
At the stent removal visit, The following 
assessments must be performed, and data 
points collected: 
• 
Stent performance assessment 
enroll, was technically successful 
• 
Stent explant – explant successful 
Changed to  
At the stent removal visit, the following 
assessments must be performed, and data 
points collected: 
• 
Stent performance assessment – 
performed as indicated during the 
planned indwell time, as assessed 
by study physician  
Stent explant – explant successful; time of 
explant 
Providing clarification that stent 
performance assessment should 
be completed only by physician 
participating in the study. Time 
of explant added to the 12 hour 
minimum stent placement time 

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10.8 Stent Removal 
Visit (maximum 
indwell time as 
indicated in individual 
stent IFU/DFU) 
• 
Added: If stents are removed 
inadvertently before intended 
indwell time, a device event 
assessment should be 
completed, and post-stent 
removal visit should be 
completed as indicated in 
section 10.9 and schedule of 
events table. 
Providing clarification on data 
collection 
11.1.1.3 Statistical 
Methods 
For each other Double-J ureteral stent in 
the study, the technical success rates will 
be summarized by descriptive statistics 
including 95% confidence intervals by 
indication (i.e. stone management, benign 
obstruction, and malignant obstruction) 
respectively.    
Changed to  
For non Tria™ Double-J ureteral stents in 
the study, the technical success rates will 
be summarized by descriptive statistics 
including 95% confidence intervals by 
indication (i.e. stone management, benign 
obstruction, and malignant obstruction) 
respectively for each device type.    
Clarifying the description of 
non-Tria stents analysis  
Section 12 Health 
Economics Outcome 
An economics analysis may be executed 
after the completion of this trial study 
depending on the clinical findings. 
Changed to  
An economics analysis may be executed 
after the completion of this trial study. 
Deleted ambiguous language 

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Section 18.1 
Reportable Events by 
investigational site to 
Boston Scientific 
 
It is the responsibility of the investigator to 
assess and report to BSC any event which 
occurs in any of following categories: 
• 
All Serious Adverse Events 
• 
All Device Deficiencies 
• 
All Device Related Adverse 
Events (including Study Stent 
implant and explant related 
events) 
Changed to  
It is the responsibility of the investigator to 
assess and report to BSC any event which 
occurs in any of following categories: 
• 
All Serious Adverse Events 
• 
All Device Deficiencies 
• 
All Adverse Device Effects  
• 
All Adverse Events related to 
the Index Procedure (inclusive 
of Study Stent Implant 
Procedure) and Study Stent 
Removal Procedure. 
Adverse events to be reported include both 
anticipated and expected post procedural 
events, (such as pain, hematuria, urgency, 
frequency, etc.) in addition to any other 
unanticipated and unexpected events. 
Providing clarification for 
Adverse and Device events 
being collected for the study 

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Section 18.3 
Relationship to 
Device(s), Index 
Procedure (including 
Study Stent Implant 
Procedure), and Study 
Stent Removal 
Procedure 
Section Header Relationship to Device(s) 
Changed to  
Relationship to Device(s), Index 
Procedure (including Study Stent Implant 
Procedure), and Study Stent Removal 
Procedure 
Providing clarification on 
assessment on AE relationship 
to device and procedures  
Section 18.3 
Relationship to 
Device(s), Index 
Procedure (including 
Study Stent Implant 
Procedure), and Study 
Stent Removal 
Procedure 
The Investigator must assess the 
relationship of the reportable AE to the 
device, or procedure, including the study 
stent removal procedure. 
Changed to  
The Investigator must assess the 
relationship of the reportable AE to the 
device, or Index procedure (including 
Study Stent Implant Procedure), and the 
study stent removal procedure. 
Providing clarification on 
assessment on AE relationship 
to device and procedures 
Table 18.3 
Removed Unlikely Related Classification 
 
Section 18.4 
Investigator 
Reporting 
Requirements 
 
Removed: The investigator must report 
Adverse Device Effects, Serious Adverse 
Events (regardless of relationship to 
device and/or procedure), Device 
Deficiencies for each subject from the 
time of index procedure through the end 
of study participation, and any 
asymptomatic stent migration. 
Removed to make language 
consistent with the previous 
section 
Section 18.4 
Investigator 
Reporting 
Requirements 
 
The paper AE Notification Form or Device 
Deficiency Notification Form should be 
used to report AEs and/or device 
deficiencies during this time. 
Changed to  
 
Providing clarification on how to 
notify sponsor of AE and device 
deficiency in case EDC is not 
available.  

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Justification for Modification 
The paper AE Notification Form or 
Device Event Notification Form should 
be used to report AEs and device events, 
including device deficiencies as applicable 
during the time when EDC system is 
unavailable. 
Section 18.7 Subject 
Death Reporting  
Added Autopsy report (if applicable) to If 
the Subject expired outside of the hospital 
(e.g., home) 
Added requirement for autopsy 
report in case of subject death 
Section 20.2 
Independent Medical 
Reviewer 
The IMR will review a safety event 
dossier, which may include copies of 
subject source documents provided by 
study sites, for all reported cases of 
device deficiencies, procedure related 
AEs, ADEs, SADEs, and all SAEs for 
TriaTM. 
Changed to  
IMR will also review and adjudicate all 
imaging and deaths reported by study 
investigators regardless of the stent 
type. The IMR will review a safety event 
dossier, which may include copies of 
subject source documents provided by 
study sites. 
Providing clarification on IMR 
responsibilities 
Section 23.1 Subject 
Reimbursement  
Added Subject Reimbursement 
For the completion of post-stent removal 
follow-up visit, subjects will be 
compensated for participation in the study, 
in accordance with pertinent country laws 
and regulations and per the study site’s 
regulations.   
Subject reimbursement for that 
last follow-up visit (post stent 
removal visit) option is added. 
This visit is not SOC for all 
regions and subjects will be 
compensated for their time to 
come to clinic to complete the 
visit. 

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Throughout Document 
Instructions for use (IFU) was added to all 
references of Directions for use (DFU). 
Added Instructions for use to 
protocol in anticipation of the 
change in nomenclature being 
adapted for DFUs.  
Throughout 
Document 
Minor typographical errors were corrected 
throughout the document 
Typographical errors are 
corrected 
Rev C 
January 15, 
2021 
92120219_R
ev/Ver F 
TITLE 
Added “PLUS” to title. 
Boston Scientific Double-J PLUS Ureteral 
Stent Postmarket Patient Registry – DJUS 
PLUS Registry 
Registry now includes non-
Double-J stents and the 
additional term PLUS allows for 
inclusion of non-Double J 
ureteral stents. 
Contact Information 
Contact Information: Removed Sameera 
Dasari; added Debra Jovanovich. Contact 
Information: Updated Northwestern 
University affiliation and contact 
information for Dr. Krambeck. 
Updated section for accuracy 
(Clinical Contact only). 
Section 2 Synopsis 
Added: Boston Scientific Urinary 
Diversion Stents are indicated for 
drainage following percutaneous, 
endoscopic, or operative procedures 
Added Indication for Use for 
new stent type. 
Section 2. Protocol 
Synopsis;  
Section 5.  
Commerical Device 
Description 
Device/System applied as standard of care:  
Added: Contour™ and Contour VL™ 
Injection Ureteral Stents; Percuflex™  
Urinary Diversion Stent (UDS); 
Polaris™  Loop Ureteral Stent; 
Contour™, Contour VL™ and  
Percuflex™ Plus SureDrive™  Steerable 
Ureteral Stent Set, an associated 
accessory devices. 
Added: An Investigational Brochure is 
not required, as commercial product 
Additional stents/accessories 
added to registry. The stents 
removed are no longer in 
production and therefore will not 
be studied in this registry. Tria 
stents were separated to Tria 
Soft and Tria Firm for clarity.  
 
 

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Justification for Modification 
information is available for BSC 
ureteral stents. 
Added: Sec 5.3 Device Accountability 
Per ISO 14155, investigational 
brochure and device 
accountability may not be 
required if justification is 
provided. 
Section 2. Protocol 
Synopsis;  
Section 7.1 - Figure 
7.1 
Study Design Chart: Modified planned 
indwell time flow chart  
 
The flow chart was updated for 
clarity. 
Section 2. Protocol 
Synopsis;  
Section 6 – Study 
Objectives and 
Endpoints; Section 
11.1.1 Primary 
Efficacy Endpoint 
 
Primary efficacy endpoint clarified and 
changed to:  
For all stents except UDS: Technical 
Success defined as stented kidney drains 
(to bladder) during the planned indwell 
time with no re-intervention due to 
obstruction of the stented ureters 
For UDS: Technical success defined as 
drainage following stent placement 
during the planned indwell time with no 
re-intervention for obstruction 
Primary Endpoints clarified for 
different stent types. 
Section 2. Protocol 
Synopsis;  
Section 6 – Study 
Objectives and 
Endpoints; Section 
11.3.1.2 Additional 
Endpoint 2 – Ureteral 
Stent Migration 
Stent Migration exception note was further 
clarified. 
Note: Movement of a stent by external 
force or by inadvertent pulling is not 
considered a stent migration. 
Stent migration definition was 
revised to provide clarity that 
stent movement caused by an 
external force does not meet the 
study definition of stent 
migration. 

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Justification for Modification 
Section 2. Protocol 
Synopsis; Section 7.1 
Scale and Duration 
 
Number of Subjects: Increased to 1000; 
Number of sites: Increased to 35 sites 
(Up to 15 sites within the United States; 
Up to 5 sites within Canada; Up to 10 
sites within Europe; Up to 5 sites within 
Japan) 
Increasing to accommodate as 
data for more stent types is being 
collected and additional sites 
may be required to complete 
enrollment. 
Section 2. Protocol 
Synopsis; Section 8.2 
Inclusion Criteria 
 
Added: For all ureteral stent types 
except UDS: 
Subject is undergoing placement of a 
Boston Scientific Double-J Ureteral 
Stent(s) included in the registry 
Added: Inclusion criteria for UDS:  
• 
Subject is undergoing placement of 
a Boston Scientific Urinary 
Diversion Stent(s) 
• 
The anatomical features of the 
involved renal collecting system are 
known by either prior or concurrent 
urography or axial CT imaging 
• 
Subject is willing and able to return 
for all follow-up visits. 
Subject population for UDS do 
not have the same requirements 
as subject population for ureteral 
obstruction. Hence inclusion 
criteria for UDS is specified 
separately. 
Section 2. Protocol 
Synopsis; Section 8.3 
Exclusion Criteria 
 
Addition: 
Subjects undergoing placement of a BSC 
US or UDS who meet any one of the 
following criteria (Table 8.3) cannot be 
included in this study or will be excluded 
from this clinical study.  
For subjects receiving bilateral/multiple 
stenting, the final exclusion criterion is 
Clarifying that exclusion criteria 
are the same for all subject 
populations; Subjects who 
receive multiple stents that are 
not the same type have not met 
all eligibility criteria and should 
be exited from study. 

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confirmed during the stent placement 
procedure. 
Section 4. 
Introduction 
Addition of background regarding 
urinary diversion 
Providing background literature 
for urinary diversion procedure. 
Section 5.2 Medical 
Equipment 
Description 
Addition of accessories used in the 
placement of UDS 
Clarifying what BSC accessories 
may be used with urinary 
diversion procedures. 
Section 7.2 Treatment 
Assignment; Section 
9.4 Subject Status and 
Classification 
Delete: and met all the eligibility criteria. 
Clarify enrollment definition to 
align with ISO 14155. 
Section 10 Study 
Methods 
Addition of COVID-19 Assessment at 
baseline and all follow-up visits, if 
available. 
Based on current pandemic 
Table 10.1: Data 
Collection Schedule;  
Addition:QoL Questionnaires 
(PROMIS®) (Except for UDS) 
Post-stent Removal visit: Laboratory 
Blood Test: Collected only if SOC, not 
required per protocol. 
Pain questionnaires are not 
relevant to UDS subject. 
The lab tests at post-stent 
removal visit is not SOC for all 
centers. Visit may be completed 
remotely, assessment is optional. 
Section 10.5 Baseline 
Visit 
Added: Chemotherapy and radiation 
treatment history  
Note: QoL Questionnaires not required 
for subjects receiving UDS  
Treatments are relevant to UDS 
subjects; Pain questionnaires are 
not relevant to UDS subject.  
 
Section 10.6 Index 
Procedure 
Added: Index procedure is defined as the 
start time of sedation and/or anesthesia. 
 
Clarified data will be collected on Stent 
Positioner and UDS accessories  
Further clarification of 
definitions, what data will be 
collected and provided examples 
of inadvertent stent removal. 

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Justification for Modification 
 
Added: 
Note: External force or inadvertently 
pulled stents are not considered Stent 
migration.  Inadvertent study stent 
removal should be reported as stent 
dislodgement if it occurs during the 
planned indwell time and was caused by 
an action other than the subject’s 
decision to remove the study stent. 
Section 10.9 Post-
Stent Removal visit 
Added: The visit may occur in the office 
or by telephone.  Laboratory Blood Test: 
Collected only if SOC, not required per 
protocol. 
Aligned with SOC.  The office 
visit and lab tests at post-stent 
remocal visit is not SOC for all 
centers. Visit may be completed 
remotely, Lab Assessment is 
optional. 
Section 13.1 Data 
Collection, Processing 
and Review 
Addition of language on Database lock and 
archiving procedures at the end of the 
study 
Protocol template change 
providing clarification on the 
database management at the end 
of the study. 
Section 13.2 
Questionnaires 
Addition of language to clarify 
questionnaires may be self-completed by 
subject or telephone administered by 
delegated research staff.  
Remote follow-up visits have 
increased due to pandemic with 
allowance for telephone 
administration of questionnaires. 
Section 14 Deviations 
Removed classification of Major and 
Minor deviations. 
Aligning to revised BSC post-
market protocol template. 
Section 15 
Compliance 
Removed Japan Medical Device GCP 
statement.  
Regulation is required for pre-
market studies only. 

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Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol Section 
Modified 
Summary of Changes 
 
Justification for Modification 
Section 15.2 
Investigator 
Responsibilities 
Addition of language that Curriculm Vitae 
and Financial Disclosure are required for 
all investigators 
Clarification on the sponsor 
requirements. 
Section 16 Monitoring 
The sponsor will put a plan in place to 
document the specific monitoring 
requirements. 
Addition of remote monitoring visit type  
Clarification on the Monitoring 
plan and type of visits. 
Section 18.1 
Reportable events by 
investigational sites to 
Boston Scientific 
• 
All Serious Adverse Events  
• 
All Device Deficiencies 
• 
All Adverse Device Effects  
• 
All Adverse Events related to the 
Index Procedure (inclusive of 
Study Stent Implant Procedure) 
and Study Stent Removal 
Procedure. 
Changed to  
• 
Serious Adverse Device Effects  
• 
Serious Adverse Events related 
to the Index Procedure 
(inclusive of Study Stent 
Implant Procedure) and Study 
Stent Removal Procedure  
• 
Serious Adverse Events 
resulting in death (regardless of 
relatedness to the study device 
and/or procedure, i.e., Index, 
Stent Implant, and/or Stent 
Removal)  
• 
Device Deficiencies 
• 
Adverse Device Effects  
Clarification on type of adverse 
events collected in the study.  

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Version 
Protocol 
Date 
Template 
number 
and version 
Protocol Section 
Modified 
Summary of Changes 
 
Justification for Modification 
• 
Adverse Events related to the 
Index Procedure (inclusive of 
Study Stent Implant Procedure) 
and Study Stent Removal 
Procedure. 
Section 18.2 Safety 
Definitions 
Addition of Serious Health Threats, 
Hospitalizations and Prolonged 
Hospitalizations 
Modifications in compliance 
with ISO 14155:2020. 
Section 18.4 Safety 
Reporting; Section 
18.5 Study Device 
Deficiencies 
Changed Device Event to Device 
Deficiency throughout protocol and 
clarified definition for Stent Migration and 
Stent Dislodgement. 
Removed the differentiation of 
Device Deficiency or Device 
Event.  If reportable, it will be a 
possible Device Deficiency. 
Section 21.1.1 Criteria 
for premature 
termination of the 
study 
Addition of 
• 
Suspicion of an unacceptable risk, 
including serious health threat. In this 
case, the sponsor shall suspend the 
clinical investigation while the risk is 
assessed. The sponsor shall terminate 
the clinical investigation if an 
unacceptable risk which cannot be 
controlled is confirmed. 
• 
Instructions by the IRB/EC/REB or 
regulatory authorities to suspend or 
terminate the clinical investigation. 
Clarification on unacceptable 
risks that could lead to study 
termination. 
Section 22 Study 
Registration and 
Results 
Addition of Study registration 
information and clinical investigational 
report 
Providing further details on 
where the study will be 
registered and publication of the 
study results upon completion of 
the study. 
Section 23.1 Subject 
Reimbursement  
Removed Subject Reimbursement 
for the completion of post-stent removal 
follow-up visit   
This visit is not SOC and the 
protocol now allows visit to be 
completed in clinic or by 

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number 
and version 
Protocol Section 
Modified 
Summary of Changes 
 
Justification for Modification 
telephone which removes the 
need for subject stipend that was 
added for their travel time to 
complete the visit. 
Throughout 
Document 
Reference to Double-J where no long 
relevant 
Addition of non-Double-J stents 
such as Polaris Loop and 
Percuflex Urinary Diversion 
Stents. 
Throughout 
Document 
Minor typographical errors were 
corrected throughout the document 
Typographical errors are 
corrected. 
Rev D 
September 
15, 2021 
92120219_R
ev/Ver G 
Synopsis – Follow-up 
schedule 
Study procedures and follow-up visits 
will may occur as follows: 
 
•Post-Stent Removal: Typically, 3 – 12 
weeks from Stent Removal 
Minor change to clarify that 
follow-up visit windows are 
recommendations based on 
current Standard of Care. 
Subject visits completed outside 
of the target dates will not 
require a “visit completed 
outside of window” protocol 
deviation. 
7.1 Scale and 
Duration 
Minor typographical error corrected:  
Target enrollment of 142 subjects enrolled 
for Polaris Ultra Ureteral stent and 25 
subjects enrolled for each additional stent 
type as outlined below: 
Enrollment discrepancies noted 
between text and table.  
Enrollment targets outlined in 
Table are correct. 
Section 18 Safety 
Reporting 
Safety Definition Tables revised to align 
with revised European Regulations 
Required for Ethic Committee 
approval for investigational sites 
in Europe  

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Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol Section 
Modified 
Summary of Changes 
Justification for Modification 
Protocol 
Implementation Plan 
Protocol Rev D will only be 
implemented in Europe. 
Protocol Rev C will continue to be 
implemented in all regions except 
Europe. 
Note: Protocol Rev B was not 
implemented in any regions due to the 
required revisions included in Protocol 
Rev C. 
Protocol Rev D includes 
administrative changes and 
clarifications only.  Section 18 
Safety Reporting regulation 
updates are only required in 
Europe. 

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2. 
Protocol Synopsis 
Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
DJUS PLUS Registry 
Study 
Objective(s) 
To obtain postmarket safety and efficacy data on Boston Scientific 
(BSC) Ureteral Stents 
Indication(s) for 
Use  
Boston Scientific Ureteral Stents are indicated for use to facilitate 
drainage from the kidney to the bladder, via endoscopic or fluoroscopic 
placement by a trained physician 
Boston Scientific Urinary Diversion Stents are indicated for drainage 
following percutaneous, endoscopic, or operative procedures 
Device/System 
applied as 
Standard of 
Care  
Boston Scientific Ureteral Stents, including (but not limited to):  
• Contour™ Ureteral Stent 
• Contour VL™ Ureteral Stent  
• Contour™ Injection Ureteral Stent 
• Contour VL™ Injection Ureteral Stent 
• Percuflex™ Ureteral Stent 
• Percuflex™ Plus Ureteral Stent 
• Percuflex™ Urinary Diversion Stent (UDS) 
• Polaris™ Ultra Ureteral Stent 
• Polaris™ Loop Ureteral Stent 
• Tria™ Soft Ureteral Stent 
• Tria™ Firm Ureteral Stent 
• Contour™ SureDrive™ Steerable Ureteral Stent Set 
• Contour VL™ SureDrive™ Steerable Ureteral Stent Set 
• Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 
Study Design 
A prospective multi-center global registry 

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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
DJUS PLUS Registry 
 
 
Planned 
Number of 
Subjects 
Up to 1,000 subjects in the Registry. 
Target enrollment of 25 subjects per stent type, unless otherwise noted 
Planned 
Number of 
Sites/ Countries 
Up to 35 sites will enroll in the Registry: 
• Up to 15 sites within the United States 
• Up to 5 sites within Canada 
• Up to 10 sites within Europe 

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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
DJUS PLUS Registry 
• Up to 5 sites within Japan 
Primary 
Endpoints 
The primary endpoints are: 
• Primary safety endpoint: Serious Adverse Device Effects 
(SADEs) 
• Primary efficacy endpoint:  
o 
For all stents except UDS: Technical Success defined as 
stented kidney drains (to bladder) during the planned indwell 
time with no re-intervention due to obstruction of the stented 
ureters 
o 
For UDS: Technical Success defined as drainage from the 
kidney following stent placement during the planned indwell 
time with no re-intervention for obstruction 
Additional 
Endpoints 
The additional endpoints are: 
• Quality of Life (QoL) – Patient-Reported Outcomes 
Measurement System (PROMIS®) for subjects ≥18 years 
o PROMIS Adult Short Form v1.0 – Pain Intensity 3a  
o PROMIS Adult Short Form v1.0 – Pain Interference 6b 
• Stent Migration: defined as any post procedure movement of the 
stent (either proximally towards the kidney or distally towards 
the bladder or complete distal migration) from its implant 
location; confirmed via imaging where necessary 
Note: External force or inadvertently pulled stents are not considered stent 
migration. 
Method of 
Assigning 
Subjects to 
Treatment 
This is an open-label postmarket registry 
 
Follow-up 
Schedule 
Each subject will be followed for a period up to 15 months after the 
Index Procedure depending on the intended stent indwell time. Study 
procedures and follow-up visits may occur as follows: 
• Baseline Visit 
• Index Procedure: Entirety of procedure including Stent Implant  
• Post-Procedure Follow-up Visit (only if Long term indwell of greater 
than 90 days): ≤ 90 days from Index Procedure  

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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
DJUS PLUS Registry 
• Stent Removal: Typically, within 2 weeks to < 365 days from 
Index Procedure (see individual stent Instructions/Directions for 
use [IFU/DFU] for maximum indwell) 
• Post-Stent Removal: Typically, 3 – 12 weeks from Stent 
Removal 
Study Duration 
The study will take approximately 50 months from First Subject In 
until Last Subject Last Visit (dependent on stent indwell time) and 
study closeout.  
• Enrollment of up to 1,000 subjects will take approximately 30 
months 
• The registry will be considered complete after all active subjects 
have completed their final follow-up visit and a final study report 
is generated    
Participant 
Duration 
The study duration for each subject is expected to be approximately 
between 8 weeks and 15 months (dependent on the study stent indwell 
time) 
Inclusion 
Criteria 
Enrollment is limited to the following inclusion criteria: 
For all ureteral stent types except UDS: 
• Subject is undergoing placement of a Boston Scientific  Ureteral 
Stent(s) included in the registry 
• Subject anatomy is appropriate to accommodate a stent size 
available in the study 
• Subject is able to accurately detect and report bladder function 
and pain 
• Subject is willing and able to: 
o Complete patient QoL questionnaire at specified time 
points (for subjects aged ≥ 18 years) 
o Return for all follow-up visits 
 
For UDS only: 
• Subject is undergoing placement of a Boston Scientific Urinary 
Diversion Stent(s) 

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Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry 
DJUS PLUS Registry 
• The anatomical features of the involved renal collecting system 
are known by either prior or concurrent urography or axial CT 
imaging 
• Subject is willing and able to return for all follow-up visits  
Exclusion 
Criteria 
Subject undergoing placement of a BSC US or UDS is not permitted to 
enroll if they meet any of the following exclusion criteria: 
• Subject meets any of the contraindications as per individual stent 
IFU/DFU  
• Subject receiving different stent type in case of bilateral/multiple 
stenting 
• Subject with an indwelling ureteral stent(s) not planned to be 
removed prior to/or concurrently with the study stent implant  
Primary 
Statistical 
Hypothesis 
The study is being statistically powered for only Tria™ implanted 
subjects for Stone Management.  
Tria™ stents have technical success during planned indwell in more 
than 85% in stone management. 
The null and alternative hypotheses are:  
H0: p ≤ 0.85 
H1: p > 0.85 
where p = the proportion of stented ureter(s)with technical success  
Statistical Test 
Method 
The hypotheses above will be evaluated based on the two-sided 95% 
exact Clopper-Pearson confidence interval for the proportion of stented 
ureters with technical success. Only stents placed at least 12 hours will 
be included in the analysis. If the lower bound of the confidence interval 
exceeds 85%, the alternative hypothesis will be demonstrated  
Sample Size 
Parameters 
Assuming that the Tria™ stent technical success rate is 94% for Stone 
Management, a sample size of 127 subjects with Tria™  placed at least 
12 hours for Stone Management is required to attain 90% power to 
demonstrate the primary hypothesis at the 2.5% significance level(one-
sided). Approximately 142 Stone Management subjects with Tria™ 
stent procedures where stents indwell at least 12 hours will be required 
to allow for 10% subject attrition 
 
 

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3. 
Table of Contents 
1. 
TITLE PAGE  .........................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................22 
3. 
TABLE OF CONTENTS .......................................................................................................27 
3.1. Table of Figures and Tables .................................................................................31 
4. 
INTRODUCTION.................................................................................................................32 
4.1. Background ............................................................................................................32 
4.2. Study Rationale .....................................................................................................33 
5. 
COMMERCIAL DEVICE DESCRIPTION (PART OF STANDARD OF CARE) ..........................34 
5.1. Commercial Device ...............................................................................................34 
5.2. Medical Equipment Description ..........................................................................35 
5.3. Device Accountability ...........................................................................................35 
6. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................................35 
7. 
STUDY DESIGN .................................................................................................................36 
7.1. Scale and Duration ................................................................................................37 
7.2. Treatment Assignment ..........................................................................................39 
7.3. Justification for the Study Design ........................................................................39 
8. 
SUBJECT SELECTION ........................................................................................................39 
8.1. Study Population and Eligibility ..........................................................................39 
8.2. Inclusion Criteria ..................................................................................................39 
8.3. Exclusion Criteria .................................................................................................40 
9. 
SUBJECT ACCOUNTABILITY .............................................................................................41 
9.1. Point of Enrollment ...............................................................................................41 
9.2. Withdrawal ............................................................................................................41 
9.2.1. 
Voluntary Withdrawal ..............................................................................41 
9.3. Lost to Follow-up...................................................................................................42 
9.4. Subject Status and Classification .........................................................................42 

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9.5. End-of-Study Definition........................................................................................42 
10. STUDY METHODS .............................................................................................................43 
10.1. Data Collection ......................................................................................................43 
10.2. Study Candidate Screening ..................................................................................45 
10.2.1. Strategies for Recruitment and Retention .................................................45 
10.3. Informed Consent..................................................................................................45 
10.4. Screening Assessments/Procedures .....................................................................45 
10.5. Baseline Visit [up to 45 days prior to Index procedure] ....................................45 
10.6. Index Procedure –BSC Ureteral Stent Placement .............................................46 
10.7. Post-procedure Follow-up (only for planned indwell greater than 90 days) ...46 
10.8. Stent Removal Visit (maximum indwell time as indicated in individual stent 
IFU/DFU) ...............................................................................................................47 
10.9. Post-Stent Removal Visit (Typically, 3 to 12 weeks) from stent removal visit 48 
10.10. 
Unscheduled Visit ...................................................................................48 
10.11. 
Study Completion ...................................................................................48 
10.12. 
Local Laboratory documentation .........................................................49 
10.13. 
Source Documents ..................................................................................49 
11. STATISTICAL CONSIDERATIONS ......................................................................................49 
11.1. Endpoints ...............................................................................................................49 
11.1.1. Primary Efficacy Endpoint – Technical Success ......................................49 
11.1.1.1. Hypotheses ...............................................................................49 
11.1.1.2. Sample Size ..............................................................................50 
11.1.1.3. Statistical Methods ...................................................................50 
11.1.2. Primary Safety Endpoint - SADE .............................................................50 
11.1.2.1. Hypotheses ...............................................................................51 
11.1.2.2. Statistical Methods ...................................................................51 
11.2. General Statistical Methods .................................................................................51 
11.2.1. Analysis Sets .............................................................................................51 
11.2.2. Control of Systematic Error/Bias ..............................................................51 
11.2.3. Number of Subjects per Investigative Site ...............................................51 
11.3. Data Analyses ........................................................................................................52 
11.3.1. Other Endpoints/Measurements ................................................................52 
11.3.1.1. Additional Endpoint 1 - QoL ...................................................52 
11.3.1.2. Additional Endpoint 2 - Ureteral Stent Migration ...................52 

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11.3.2. Interim Analyses .......................................................................................52 
11.3.3. Subgroup Analyses ...................................................................................53 
11.3.4. Justification of Pooling .............................................................................53 
11.3.5. Multivariable Analyses .............................................................................53 
11.3.6. Changes to Planned Analyses ...................................................................53 
12. HEALTH ECONOMICS OUTCOMES ...................................................................................53 
13. DATA MANAGEMENT .......................................................................................................53 
13.1. Data Collection, Processing, and Review ............................................................53 
13.2. Questionnaires .......................................................................................................54 
13.3. Data Retention .......................................................................................................54 
14. DEVIATIONS......................................................................................................................54 
15. COMPLIANCE ....................................................................................................................55 
15.1. Statement of Compliance ......................................................................................55 
15.2. Investigator Responsibilities ................................................................................55 
15.2.1. Delegation of Responsibility ....................................................................57 
15.3. Institutional Review Board/ Ethics Committee ..................................................57 
15.4. Sponsor Responsibilities .......................................................................................58 
15.5. General Data Protection Regulations (GDPR) ...................................................58 
15.5.1. Transparency .............................................................................................59 
15.5.2. Rights to Data Subjects .............................................................................59 
15.6. Insurance ................................................................................................................60 
16. MONITORING ....................................................................................................................60 
17. POTENTIAL RISKS AND BENEFITS ...................................................................................60 
17.1. Instructions/Directions for Use ............................................................................60 
17.2. Risks associated with Participation in the Clinical Study .................................60 
17.3. Possible Interactions with Concomitant Medical Treatments, if applicable ...60 
17.4. Risk Minimization Actions ...................................................................................60 
17.5. Anticipated Benefits ..............................................................................................61 
18. SAFETY REPORTING .........................................................................................................61 
18.1. Reportable Events by investigational site to Boston Scientific .........................61 

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18.2. Definitions and Classification...............................................................................62 
18.3. Relationship to Device(s), Index Procedure (including Study Stent Implant 
Procedure), and/or Study Stent Removal Procedure .........................................64 
18.4. Investigator Reporting Requirements .................................................................66 
18.5. Study Device Deficiencies .....................................................................................68 
18.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators .......68 
18.7. Subject Death Reporting ......................................................................................68 
19. INFORMED CONSENT ........................................................................................................69 
20. COMMITTEES ...................................................................................................................71 
20.1. Safety Monitoring Process ....................................................................................71 
20.2. Independent Medical Reviewer ...........................................................................71 
20.3. Steering Committee ...............................................................................................71 
21. SUSPENSION OR TERMINATION........................................................................................72 
21.1 Premature Termination of the Study ..................................................................72 
21.1.1 
Criteria for Premature Termination of the Study ......................................72 
21.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC/REB Approval .......................................................................................72 
21.3 Requirements for Documentation and Subject Follow-up ................................72 
21.4 Criteria for Suspending/Terminating a Study Site ............................................73 
22. STUDY REGISTRATION AND RESULTS .............................................................................73 
22.1. Study Registration .................................................................................................73 
22.2. Clinical Investigation Report ...............................................................................73 
23. PUBLICATION POLICY ......................................................................................................74 
24. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................74 
24.1. Subject Reimbursement ........................................................................................74 
24.2. Compensation for Subject’s Health Injury.........................................................74 
25. BIBLIOGRAPHY .................................................................................................................75 
26. ABBREVIATIONS AND DEFINITIONS .................................................................................76 
26.1. Abbreviations.........................................................................................................76 

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26.2. Definitions ..............................................................................................................77 
27. APPENDICES .....................................................................................................................80 
27.1. Appendix 1 Ureteral Stent Product Codes..........................................................80 
27.2. Appendix 2 Clavien-Dindo Classification ...........................................................90 
 
 
3.1. Table of Figures and Tables 
Figure 7.1: BSC Ureteral Stent Registry Study Design 
38 
Table 8.2: Inclusion Criteria 
40 
Table 8.3: Exclusion Criteria 
40 
Table 10.1: Data Collection Schedule 
44 
Table 18.2: Safety Definitions 
62 
Table 18.3: Criteria for Assessing Relationship of Study Device, Index Procedure (including 
Study Stent Implant Procedure), and Study Stent Removal Procedure to Adverse Event 
65 
Table 18.4: Reporting Timelines 
67 
Table 26.1: Abbreviations 
76 
Table 26.2: Definitions 
77 
 
 

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4. 
Introduction 
4.1. Background 
Ureteral stents have been available for several decades and are commonly used to restore 
flow of urine from the kidney to the bladder in obstructed ureters, or as a prophylactic 
placement following procedural interventions in the ureter to ensure that flow is not 
compromised during the acute post-procedural period.  Stents may also be used for long-term 
drainage in patients with strictures or tumors, or to aid in ureteral healing after an accidental 
ureteral perforation or a therapeutic ureterotomy.  With such a wide variety of uses, ureteral 
stents may remain indwelling for periods as short as 48 hours or up to as long as 365 days 
(see individual stent Instructions/Directions for Use (IFU/DFU) for maximum indwell time). 
One such use of ureteral stents is temporary stenting following ureteroscopic treatment of 
upper urinary tract stones.  These stones can range in size from a few millimeters to a few 
centimeters and are generally made up of mineral and acid salts, with 70-80% of kidney 
stones being made of calcium oxalate.   The remaining make up of stones are split by those 
composed of struvite, uric acid and calcium phosphate. (Satyanand, Patel, Patel, Tarun, & 
Soniya, 2012) In a 2007-2010 survey showed kidney stone prevalence in the United States 
population estimated to be 10.6% for men and 7.1% for women with an overall unadjusted 
prevalence to be 8.8%. (Ziemba & Matlaga, 2017) 
 
Treatment decisions for stones are determined at the individual case level and take into 
account stone size, stone location, and (if known) stone composition, as well as patient 
preference and physician expertise. Current treatment recommendations are generally 
endourologic procedures such as ureteroscopy (URS), shock wave lithotripsy (SWL), and 
percutaneous nephrolithotomy (PCNL). (Türk, et al., 2016)  Ureteral stents are placed after 
ureteroscopy for stone removal to prevent pain (Torricelli, De, Hinck, Noble, & Monga, 
2014) and to aid in future removal of residual stone fragments. (Chen, Tsai, Yu, Wu, & Lin, 
2013)  Thus, ureteral stents are a fundamental part of a urologic stone practice. Further, 
ureteral stents have been used for maintaining luminal patency in ureteral obstruction, 
including cases of malignant ureteral obstruction due to pelvic malignancy. If urine flow to 
the bladder is not possible, a ureteral stent is placed in the kidney to facilitate drainage 
following ureteral conduit construction and urinary diversion procedures; rerouting of urine 
flow to an opening in the wall of the abdomen (stoma). This stenting provides greater 
assurance of sustained internal urinary diversion, in addition to lessening concerns regarding 
anastomotic leaks from the pouch.   
 
While usually used temporarily, occasionally patients may have long-term stent placement.  
Long-term indwell of a ureteral stent increases the risk of encrustation (accumulation of urine 
salts on the surface of the stent) and can lead to serious and difficult complications such as 
ureteral obstruction and renal impairment.  The most common contributors to encrustation 
include urinary tract infection, extended indwell times (for chronic strictures or forgotten 
stents), urinary composition (hypercalciuria, hyperoxaluria, hypocitraturia, homocystinuria, 
and hyperuricosuria), and history of urolithiasis.  Severely encrusted and retained stents are 

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serious and complex cases for the Endourologist to treat.  Since encrustation most often 
occurs in the bladder and kidney, they often require a multimodal endoscopic approach to 
achieve stent-free status. (Mohan-Pillai, Keeley, Maussa, Smith, & Tolley, 1999)  
 
Beyond encrustation, another area of interest in ureteral stents is patient discomfort.  Ureteral 
stent pain is a known side-effect of indwelling stents.  There have been various studies to 
determine the best way to measure and decrease the pain associated with ureteral stents with 
no apparent resolution for the issue.  It is hypothesized that a stent composed of a soft 
flexible material may reduce stent related discomfort.  A randomized controlled study of 155 
subjects showed a significantly higher incidence of dysuria, renal, and suprapubic pain in 
those subjects who received a firm polyurethane stent versus a soft stent. (Koprowski, Kim, 
Modi, & Elsamra, 2016)   
 
Other published studies have explored the duration of time the stent is left in place, (Ozgur, 
Ekici, Yuceturk, & Bayrak, 2013) use of image guidance in stent placement, (Grasso, et al., 
2013) length and other physical features of the inserted stent, (Calvert, et al., 2013) and 
efficacy of pre-stenting prior to ureteroscopy. (Torricelli, De, Hinck, Noble, & Monga, 2014) 
 
4.2. Study Rationale 
Under normal conditions, urine is carried from the kidneys to the bladder via the ureters. A 
ureter may become obstructed as a result of a number of conditions including kidney stones, 
tumors, blood clots, postsurgical swelling, or infection. When the urine flow is blocked, it 
backs up into the kidney, which can lead to kidney swelling or hydronephrosis, as well as 
severe pain in the abdomen, flank, or side; nausea; vomiting; and hematuria. The goal of 
treatment for ureteral obstruction is to relieve or reduce the blockage and restore urinary 
drainage. Ureteral obstruction is commonly treated via placement of a ureteral stent; a thin, 
flexible tube that is threaded into the ureter and restores the flow of urine to the bladder. The 
most common reason for urinary diversion is bladder cancer that requires the bladder to be 
removed, a procedure called a cystectomy. Urinary diversion creates a new way for urine to 
exit body when urine flow is blocked or when there is a need to bypass the urinary tract. 
 
The patient is usually placed under anesthesia for stent insertion, ensuring that the patient 
remains relaxed and immobile during the procedure. A cystoscope is inserted into the urethra 
to the bladder, and the opening to the ureter is identified. In some instances, a guidewire is 
inserted into the ureter under the aid of a fluoroscope. The stent is loaded onto the guidewire 
and subsequently advanced over the guidewire by a stent positioner (pusher). Once the stent 
is in place, the guidewire, positioner, and cystoscope are removed. If retrograde stenting is 
not possible, patients may have the stent placed percutaneously into the kidney, and 
subsequently into the ureter.  Postoperative urine flow is monitored to ensure the stent has 
not been dislodged or obstructed. The stent may remain in place on a short-term (days to 
weeks) or long-term (weeks to months) basis and is removed most often cystoscopically. A 

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stent may also be removed with the attached retrieval line by a physician or nurse in an office 
setting or by the patient at home. 
 
Although ureteral stents have been used safely in patients for over 30 years, there are limited 
clinical studies focusing specifically on the safety and efficacy of Boston Scientific’s 
Ureteral Stents. Further, Boston Scientific (BSC) is launching the Tria™ Ureteral Stent 
(available in Soft and Firm durometers) with proprietary Percushield™ surface technology 
aimed at reducing calcium and magnesium urine salt accumulations. The goal of this registry 
is to collect real-world clinical data on BSCs Ureteral Stents to address changing European 
Regulatory requirements.  In contrast to the limited published data for safety and efficacy of  
BSC Double-J Ureteral Stents, there are published clinical data sets on stent-related pain and 
Quality of Life (QoL), with many of studies showing increased side effects and reduced QoL 
associated with stent indwell (Scarneciu, Lupu, Pricop, & Scarneciu, 2015) (Lingeman, 
Preminger, Goldfischer, & Krambeck, 2009). This study will use a simplified patient QoL 
questionnaire to measure BSC stent-related pain at various times during the study; 
medications prescribed post-procedure will also be captured. These QoL data sets will be the 
first generated for the Tria™ stent family.  
 
5. 
Commercial Device Description (part of Standard of Care) 
5.1. Commercial Device  
BSC offers a broad portfolio of Ureteral stents. A few Market-approved and commercially 
available stents are included in this registry.  
 
The following market-approved devices will be evaluated: 
 
• Contour™ Ureteral Stent 
• Contour ™  SureDrive™ Steerable Ureteral Stent 
• Contour VL™ Ureteral Stent 
• Contour VL™ SureDrive™ Steerable Ureteral Stent  
• Contour™ Injection Ureteral Stent 
• Contour VL™  Injection Ureteral Stent 
• Percuflex™ Ureteral Stent 
• Percuflex™ Plus Ureteral Stent 
• Percuflex™ Plus SureDrive™ Steerable Ureteral Stent  
• Polaris™ Ultra Ureteral Stent 
• Polaris™ Loop Ureteral Stent 
• Tria™ Soft Ureteral Stent 
• Tria™ Firm Ureteral Stent 
• Percuflex™ Urinary Diversion Stent 
 

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The above list of devices could be expanded to include other BSC Ureteral Stent devices in 
this registry.  
 
A copy of the device labeling and Instructions/Directions for Use (IFU/DFU) will be 
provided in local language(s) as required per national regulation. An Investigational 
Brochure has not been developed and per ISO 14155 is not required for this postmarket 
observational clinical investigation as commercial product information is available and study 
device(s) are used within the approved indication. 
 
Appendix 1 provides a detailed list of all BSC Ureteral stents available to be used in the 
study along with their respective UPN/Product code.  
 
5.2. Medical Equipment Description 
Accessories that will be used in conjunction with the placement of a BSC Double-J Ureteral 
Stent during the procedure include the pigtail straightener and stent positioner.  BSC ureteral 
access sheaths and BSC guidewires may also be used. Accessories that may be used in 
conjunction with the placement of a BSC UDS during a urinary diversion procedure include 
guidewire, catheter adaptors and drainage bag connector.  
5.3. Device Accountability 
Boston Scientific will not conduct investigational device accountability as required per ISO 
14155 as all study devices are commercially available products and are being used within 
their approved indication. The study devices shall be maintained per each institutions 
standard practice. 
6. 
Study Objectives and Endpoints 
The objective of this study is to compile characteristics of real-world safety and efficacy 
outcomes for Boston Scientific Corporation’s commercially approved Ureteral stents, when 
used according to the applicable IFU/DFU. 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
The primary objective 
is to assess the clinical 
safety and efficacy of 
BSC Ureteral Stents 
Primary safety endpoint: 
Serious Adverse Device Effects 
(SADE)  
 
A ureteral stent is placed to 
open the ureter to allow 
passage of urine from the 
kidney, or from the kidney 
to the bladder. Any 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary efficacy endpoint: For 
all stents except UDS: 
Technical Success of the 
stents defined as Stented 
kidney drains (to bladder) 
during the planned indwell 
time with no re-intervention 
due to obstruction of the 
stented ureters 
 
For UDS: Technical success 
defined as drainage following 
stent placement during the 
planned indwell time with no 
re-intervention due to 
obstruction 
unplanned re-intervention 
due to an obstructed ureter 
would mean that there is not 
drainage from the kidney 
and the study stent failed to 
work as indicated, and there 
is an adverse event or 
serious adverse device event 
related to the stent such as 
urinary retention, dislodging 
or migration of the stent  
Additional 
 
 
Quality of Life (QoL) 
(questionnaires) 
 
Patient-Reported Outcomes 
Measurement System 
(PROMIS®) –  
• PROMIS Adult Short 
Form v1.0 – Pain 
Intensity 3a  
• PROMIS Adult Short 
Form v1.0 – Pain 
Interference 6b 
Gain information specific to 
the patient’s pain scale and 
quality of life for subjects 
treated with ureteral stents 
Ureteral Stent Migration 
Defined as any post procedure 
movement of the stent (i.e., 
either proximally towards the 
kidney or distally towards the 
bladder or complete distal 
migration) from its implant 
location; confirmed via 
imaging where necessary 
Note: Movement of a stent by external 
force or inadvertent pulling is not 
considered a stent migrations. 
Capture real-world stent 
migration rates 
 
7. 
Study Design 
The Double-J PLUS Registry is a prospective, on-label, multi-center, global registry. 

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7.1. Scale and Duration 
 
The registry will include: 
• Up to 1,000 subjects will be enrolled at up to 35 sites  
• At least 142 subjects will be enrolled for Tria™ Ureteral stent for stone 
management at sites within the United States, Europe, Canada and Japan. A 
hypothesis test will be performed for this patient group. 
• Target enrollment for each additional stent type as outlined below.  
• The enrollment period will be approximately 30 months. 
• There will be up to 15 sites in the United States; 10 in EU, 5 in Canada and 5 
in Japan.  
• The study is expected to take 50 months from first subject enrollment until the 
study closeout.  
• Each subject will be involved in the study for approximately 8 weeks to 15 
months depending on the stent indwell time, from the index procedure. 
 
 
Boston Scientific Ureteral Stents 
Target 
Enrollment 
Minimum Target 
Enrollment 
• Tria Soft and Tria Firm 
142 
142 
• Polaris Ultra 
25 
15 
• Percuflex 
25 
15 
• Contour Injection 
• Contour VL Injection 
30 
15 each 
• Contour 
• Contour SureDrive Steerable 
30 
15 each 
• Contour VL 
• Contour VL SureDrive Steerable 
30 
15 each 
• Percuflex Plus  
• Percuflex Plus SureDrive Steerable 
30 
15 each 
• Polaris Loop 
25 
15 
• Percuflex UDS 
25 
15 
 
 

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Figure 7.1: BSC Ureteral Stent Registry Study Design 
 

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7.2. Treatment Assignment 
This is a post-market registry study and any subject who intends to receive BSC Ureteral 
Stent(s) or Urinary Diversion Stent(s) and is willing to provide a written informed consent 
will be approached and considered for enrollment in the study. Subject is considered enrolled 
in the study once the subject has signed the informed consent form. Each subject will be 
assigned a unique subject identifier in the Electronic Data Capture (EDC) system.  
7.3. Justification for the Study Design 
BSC Ureteral Stents are commercially available devices to relieve or reduce ureteral 
blockage and restore urinary drainage. With a cohort study design, enrolling subjects 
receiving the stent as standard of care procedure will provide real-world data. 
8. 
Subject Selection  
8.1. Study Population and Eligibility  
Up to 1,000 implanted subjects may be included in the registry.  
Subjects will generally be recruited from physician’s practice and subject must meet the 
indications for a ureteral stent implant per the IFU/DFU. Patients who meet all of the 
following criteria (see Table 8.2) may be given consideration for inclusion in this clinical 
investigation, provided no exclusion criterion (see Section 8.3) is met. 
8.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 8.2) may be given consideration for 
inclusion in this clinical investigation, provided no exclusion criterion (see Section 8.3) is 
met.  
 

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Table 8.1: Inclusion Criteria 
Inclusion 
Criteria 
For all ureteral stent types except UDS: 
1. Subject is undergoing placement of a Boston Scientific Ureteral 
Stent(s) included in the registry 
2. Subject anatomy is appropriate to accommodate a stent size 
available in the study 
3. Subject is able to accurately detect and report bladder function and 
pain 
4. Subject is willing and able to: 
a. Complete patient QoL questionnaire at specified time points 
(for subjects aged ≥ 18 years) 
b. Return for all follow-up visits 
For UDS: 
1. Subject is undergoing placement of a Boston Scientific Urinary 
Diversion Stent(s) 
2. The anatomical features of the involved renal collecting system are 
known by either prior or concurrent urography or axial imaging 
3. Subject is willing and able to Return for all follow-up visits  
 
 
8.3. Exclusion Criteria 
Subjects undergoing placement of a BSC US or UDS who meet any one of the following 
criteria (Table 8.3) cannot be included in this study or will be excluded from this clinical 
study.  For subjects receiving bilateral/multiple stenting, the final exclusion criterion is 
confirmed during the stent placement procedure. 
 
Table 8.2: Exclusion Criteria 
Exclusion Criteria 
1. Subject meets any of the contraindications as per individual 
stent IFU/DFU  
2. Subject receiving different stent type in case of 
bilateral/multiple stenting 
3. Subject with an indwelling ureteral stent(s) not planned to be 
removed prior to/or concurrently with the study stent implant 
 

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9. 
Subject Accountability 
9.1. Point of Enrollment 
Subjects will be considered enrolled in the study after he/she signs and dates the informed 
consent (ICF).  No study specific (non-standard of care) procedure(s) or assessment(s) can 
take place until the informed consent is signed.    
 
9.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study) 
shall be accounted for and documented. If a subject withdraws from the study, the reason(s) 
shall be reported. If such withdrawal is due to problems related to device safety or 
performance, the investigator shall ask for the subject’s permission to follow his/her 
status/condition outside of the clinical study.  
 
Reasons for withdrawal include but are not limited to physician discretion and subject choice 
to withdraw consent. While study withdrawal is discouraged, subjects may withdraw from 
the study at any time, with or without reason, and without prejudice to further treatment. All 
applicable electronic Case Report Forms (eCRFs) up to the point of subject withdrawal and 
an End of Study eCRF must be completed. Additional data may no longer be collected after 
the point at which a subject has been withdrawn from the study or withdraws his/her consent. 
Data collected up to the point of subject withdrawal may be used for study analysis, unless 
local regulations apply. 
 
9.2.1. Voluntary Withdrawal 
Subjects may withdraw from the study at any time. At the time of withdrawal, the 
Investigator shall document the reason for the withdrawal. For subjects who withdraw from 
the study and decide to revoke their authorization to use and disclose their medical 
information, the information that has already been collected in the study record may continue 
to be used; however, no new information will be obtained or added. 
 
9.2.2.  Involuntary Withdrawal 
Subjects may be involuntarily withdrawn from the study if the Investigator determines it is in 
the subject’s best interest. If the subject is withdrawn at the investigator’s discretion, the 
reason for withdrawal must be documented in the subject’s medical records. Subjects who 
did not receive the study stent (implant failures) will be followed through hospital discharge 
and will be considered withdrawn.  
  

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9.3. Lost to Follow-up 
If a subject fails to return to the clinic and/or is unable to be reached for a follow-up visit the 
site will attempt to contact the subject and reschedule the missed visit and counsel the subject 
on the importance of maintaining the assigned visit schedule and ascertain if the subject 
wishes to and/or should continue in the study.  
Before the subject may be considered lost to follow-up, the investigator must make the 
following attempts to contact the subject: 
• Three documented telephone attempts 
• One certified letter 
If the subject can be reached and no longer wishes to participate in the study, the Investigator 
shall document the reason for the withdrawal and complete the End of Study eCRF. 
 
If the subject is not able to be reached after the required attempts to contact the subject have 
been made and the subject has missed two consecutive follow-up visits, or the subject has 
missed the final post-stent removal visit, the subject may be considered lost to follow-up. The 
Investigator should document in the subject’s medical record the attempts to contact the 
subject and the reason for withdrawal. 
 
9.4. Subject Status and Classification 
A subject will be considered enrolled after a signed informed consent is obtained. An 
implanted subject participation ends when he or she has completed all phases of the study 
including the last visit as shown in the Data Collection Schedule or if the study stent is 
replaced either for planned stent replacement or due to re-intervention. Subjects who are 
unable to have study stent implanted will be followed through discharge following index 
procedure and he or she will be considered withdrawn from the study.  
 
9.5. End-of-Study Definition  
A clinical study at each participating site is considered completed when participants are no 
longer being examined or the last participant’s last study visit has occurred, and study 
closeout activities are completed  
A subject is considered to have completed the study after he or she has completed all phases 
of the study including the last visit shown in the Data Collection Schedule (see section 10) or 
if the study stent is replaced either for planned stent replacement or due to re-intervention.   
The end of the study is defined as completion of the final Clinical Study Report.  
 

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10. 
Study Methods 
10.1. Data Collection 
The data collection schedule is shown in Table 10.1. Assessments will be completed based 
on standard of care practices at the site and PROMIS® pain scale questionnaires will be 
collected. All study data will be recorded on source documentation and captured within 
electronic Case Report Forms (eCRFs) for the purposes of this study. Study data will be 
monitored by Boston Scientific or representatives and as applicable on a regular basis as 
outlined in the study Monitoring Plan. 
 

 
 
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Table 10.1: Data Collection Schedule 
Procedure/Assessment 
Screening/ 
Enrollment 
Baseline 
Visit 
Index 
Procedure 
(≤ 45 days from 
Baseline visit) 
Post-Procedure Visit  
Follow-up Visits 
 Only if Long term indwell of 
greater than 90 days 
(45 – 902 days from Index 
procedure)  
Stent Removal 
Visit 
(< 3652 days from 
Index procedure) 
Post-Stent 
Removal visit 
(3-12 weeks from 
Stent Removal) 
Unscheduled 
Visit  
 
Informed consent process, including informed consent 
signature date1 
X 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X2 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Laboratory – Blood Test, Serum Creatinine and 
Glomerular Filtration Rate (GFR) 
X 
 
 
 
X5 
X 
Laboratory – Urinalysis/Culture 
UTI status and Pregnancy test4 
X 
 
 
 
 
X 
Physical Assessment: Weight, Height, BMI, and 
Temperature 
X 
 
 
 
 
 
QoL Questionnaires (PROMIS®) (Except for UDS):-
Adult Short Form v1.0 – Pain Intensity 3a 
-Adult Short Form v1.0 – Pain Interference 6b 
X - Prior to 
Implant  
 
 
X - Prior to Removal 
X 
 
Assessment of Adverse Events (including Clavien-
Dindo Classification) and Device Deficiencies 
(including stent migrations and stent dislodgements) 
 
X 
X 
X 
X 
X 
Stent Performance Assessment 
 
X 
X 
X 
 
X 
Boston Scientific Accessory Device Assessment 
 
X 
 
 
 
 
Medication Assessment (Antibiotics, NSAIDs, 
anticholinergic, narcotic/opioid, Diuretic, Phenazopyridine, Alpha 
blockers) 
 
X - Prior to 
Discharge 
 
 
 
X - Prior to 
Discharge 
Imaging3 
 
 
 
 
 
X 
COVID-19 Assessment (if available) 
X5 
 
X5 
X5 
X5 
X5 
1. 
Informed consent obtained before any study specific, non-standard of care screening tests or procedures are performed 
2. 
See individual stent IFU/DFU for contraindications and maximum indwell time 
3. 
Image to be collected if completed as Standard of care and when suspected of ureteral obstruction 
4. 
Only at the baseline visit  
5. 
Not-required; recommended if available or collected as standard of care  

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10.2. Study Candidate Screening 
All interested subjects will undergo screening during which their eligibility for the study 
will be determined.  
Subjects who do not meet the inclusion/exclusion criteria are considered screen failures.  
Information on screen failures will be captured in the screening logs and should include 
reasons for screen failure. These screen failures will not count towards the enrollment 
ceiling.  
If the subject has completed the informed consent process and met all inclusion/exclusion 
criteria, the subject will progress to the index procedure and follow-up phases of the 
study, if stent(s) is implanted. 
10.2.1. Strategies for Recruitment and Retention 
Subjects will be recruited from clinician practice who are receiving device as standard of 
care. For the completion of post-stent removal follow-up visit, subjects will be compensated 
for participation in the study, in accordance with pertinent country laws and regulations and 
per the study site’s regulations.   
10.3. Informed Consent 
Written informed consent must be obtained from all potential study candidates before any 
study specific, non-standard of care screening tests or procedures are performed. Only 
current  Institutional Review Board (IRB), Ethics Committee (EC) or Research Ethics Board 
(REB)  approved study specific ICF must be used. Study personnel should explain that even 
if a subject agrees to participate in the study and signs an ICF, certain screening procedures 
might demonstrate that the subject is not eligible to continue participation.  Written informed 
consent must be recorded appropriately by means of the subject’s dated signature.   
10.4. Screening Assessments/Procedures 
The Screening/Enrollment and Baseline visit may occur on the same day or on different days.  
The following must be completed prior to collecting baseline data described in section 10.5:  
• Informed Consent Process, including informed consent signature  
• Review of Inclusion/Exclusion Criteria 
10.5. Baseline Visit [up to 45 days prior to Index procedure] 
The Baseline Visit will occur prior to the subject having index procedure/stent placement. 
The assessments below must be completed prior to index procedure and may occur up to 45 
calendar days prior to index procedure.  

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The baseline assessments below can be completed on the same day as Index procedure, prior 
to the stent implant. 
• Demographics: Age, Gender, Race and Ethnicity 
• Diagnosis/Medical History (only active medical problems at the time of baseline 
assessment, including Neoadjuvant chemotherapy (within 6 months prior to stent 
placement for bladder cancer); Radiation status (pelvis and abdomen)) 
• Labs: Serum Creatinine, GFR 
• Urinalysis/culture: UTI status, Pregnancy test for women of child-bearing potential 
• Physical examination: Height, Weight, BMI, Temperature 
• COVID-19 assessment: prior diagnosis, test result, vaccination status (if available) 
• QoL Questionnaires (PROMIS):  
o Adult Short Form v1.0 – Pain Intensity 3a 
o Adult Short Form v1.0 – Pain Interference 6b  
Note: QoL Questionnaires not required for subjects receiving UDS 
 
10.6. Index Procedure –BSC Ureteral Stent Placement 
Index procedure is defined as the start time of sedation and/or anesthesia and includes the 
entirety of the procedure in which the study stent is implanted, however also includes ureteral 
access sheath insertion, scoping, irrigation, laser lithotripsy, basketing, etc. The stent 
placement will be performed by a trained physician and per the individual stent IFU/DFU.  
Note:  Baseline visit information may be collected on same day, prior to the index procedure.  
After the index procedure, the following data will be collected: 
• Stent Information – type, size,stent laterally (left or right), unilateral or bilateral, time 
of stent placement 
• Stent Performance Assessment – implanted and performed as indicated within 
IFU/DFU 
• Accessory Device Performance and Safety Assessment (BSC Guidewire, BSC 
Ureteral Access Sheaths {UAS}, BSC Stent Positioner, BSC UDS Accessories) - 
used during the index procedure 
• Medication Assessment (post-procedure) - antibiotics, NSAIDs, anticholinergic, 
narcotic/opioid, Diuretic, Phenazopyridine, Alpha blockers 
• Assessment of Adverse Events (including Clavien-Dindo Classification) and Device 
Deficiencies (including stent migrations and stent dislodgements) 
 
10.7. Post-procedure Follow-up (only for planned indwell greater than 90 days) 
 

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Stent indwell time should be per individual IFU/DFU. If indwell of greater than 90 days is 
planned, a post-procedure follow-up should be completed between 45 - 90 days from the 
index procedure as indicated in individual stent IFU/DFU.   
The subjects should be followed in clinic for the following data collection: 
• Stent Performance Assessment – stent performed as indicated 
• Assessment of Adverse Events (including Clavien-Dindo Classification) and Device 
Deficiencies (including stent migrations and stent dislodgements) 
• COVID-19 Assessment: New diagnosis, test result, vaccination status, if available 
If indwell of less than 90 days is planned, a post-procedure follow-up is not required. 
 
10.8. Stent Removal Visit (maximum indwell time as indicated in individual stent 
IFU/DFU) 
The stent removal should be per the individual stent IFU/DFU. The indwell time should not 
exceed indwell period indicated in the individual IFU/DFU. The stent removal shall occur 
per standard practice.   
At the stent removal visit, the following assessments must be performed and data points 
collected: 
• Stent Performance Assessment – performed as indicated during the planned indwell 
time, as assessed by study physician  
• Stent Explant – explant successful; time of explant 
• QoL Questionnaires (PROMIS): to be completed before stent removal 
o Adult Short Form v1.0 – Pain Intensity 3a 
o Adult Short Form v1.0 – Pain Interference 6b  
Note: QoL Questionnaires not required for subjects receiving Urinary Diversion Stent  
 
• Assessment of Adverse Events (including Clavien-Dindo Classification) and Device 
Deficiencies (including stent migrations and stent dislodgements) 
• COVID-19 Assessment: New diagnosis, test result, vaccination status, if available 
 
If stent is explanted in a non-study clinic facility (e.g., at home, another clinic), the 
required assessments will be completed via telephone.  
If stents are removed inadvertently before intended indwell time, the post-stent removal 
visit should be completed as indicated in section 10.9 and schedule of events table.  
 

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10.9. Post-Stent Removal Visit (Typically, 3 to 12 weeks) from stent removal visit 
The post-stent removal visit should occur between 3 – 12 weeks from the Stent Removal 
Visit.  The visit may occur in the office or by telephone.  At this visit the following 
assessments will be performed and data points collected: 
• Labs – Serum Creatinine and GFR (not required, collected if office visit and SOC) 
• QoL Questionnaires (PROMIS):  
o Adult Short Form v1.0 – Pain Intensity 3a 
o Adult Short Form v1.0 – Pain Interference 6b  
Note: QoL Questionnaires not required for subjects receiving Urinary Diversion 
Stent 
• Assessment of Adverse events (including Clavien-Dindo Classification) 
• COVID-19 Assessment: New diagnosis, test result, vaccination status, if available 
10.10. Unscheduled Visit 
Subjects may have additional visits (other than the study visits specified above), that are 
unplanned visits and are considered as unscheduled visits. Some examples of these visits may 
include a visit for a change in symptoms or to check on a medical event that could not be 
resolved during one of the scheduled study visits. 
 
If an unscheduled visit is for a suspected ureteral obstruction, the following will be attempted 
to be collected: 
• Laboratory Blood test – Serum Creatinine and GFR 
• Laboratory Urinalysis – UTI status 
• Adverse Event (including Clavien-Dindo Classification) and Device Deficiency 
(including stent migrations and stent dislodgements) Assessment 
• Stent Performance Assessment 
• Imaging 
• Medication 
• COVID-19 Assessment: New diagnosis, test result, vaccination status, if available 
 
 
10.11. Study Completion 
Each subject will be followed to the post-stent removal follow-up visit. All subjects 
completing the post-stent removal follow-up visit will be considered to have completed the 
study. Subjects with any ongoing Adverse Events at the end of the study should be followed 
per institutions SOC. 
Upon completion of the study, all adverse events indicated as “ongoing” should be changed 
to one of the following outcomes: 

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• Not Recovered/Not Resolved 
• Resolved 
• Resolved with sequelae 
• Unknown 
 
The outcome of “unknown” should only be used for subjects who are lost to follow-up. 
Whenever possible, sites should enter a reason for each ongoing/unresolved adverse event at 
time of study exit. 
10.12. 
Local Laboratory documentation 
The laboratory (blood and urine) analysis, collected in the study will be completed at the 
local centers per standard of care. Appropriate laboratory certifications and documentation 
records are required to be maintained at the site.   
10.13. Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained.  A certified copy is 
a copy (irrespective of the type of media used) of the original record that has been verified 
(i.e., by a dated signature or by generation through a validated process) to have the same 
information, including data that describe the context, content, and structure, as the original.  
 
11. 
Statistical Considerations 
11.1. Endpoints 
11.1.1. Primary Efficacy Endpoint – Technical Success 
The primary efficacy endpoint is the technical success of Tria™ in stone management. For 
all stents except UDS, technical success is defined as stented kidney drains (to bladder) 
during the planned indwell time with no re-intervention due to obstruction of the stented 
ureter(s). For UDS, technical success is defined as drainage following stent placement during 
the planned indwell time with no re-intervention for obstruction.  Restenting with a new 
study stent may only occur during the initial stent placement procedure for such situations as 
stent misplacement, improper stent size choice, or other conditions, as necessary and will not 
be considered as a primary effectiveness endpoint failure or a secondary endpoint failure for 
stricture resolution. 
11.1.1.1. Hypotheses 
The study will evaluate whether Tria™ stents have technical success during planned indwell 
in more than 85% in stone management. The null and alternative hypotheses for this 
evaluation are 

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   H0:  p ≤ 85% 
   H1: p > 85% 
where p is the proportion of stented ureter(s) with technical success.  
11.1.1.2. Sample Size  
There are two published studies on the patency in the stone management for Double J 
stents.  The success rates were 98% with a 95% CI [94%, 99%] (Calvert, et al., 2013) and 
96% with a 95% CI [92%, 99%] (El-Faqih SR, 1991).  As a result, an 94% patency rate is 
estimated as the performance for the Double J stents.  The performance goal of 85% is 
chosen for the patency for TRIA in the stone management, with a non-inferiority margin of 
9%. 
With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size 
of 127 subjects with Tria™ placed at least 12 hours for stone management are needed to 
demonstrate the proportion of stented ureters with technical success exceeds 85%. Assuming 
a 10% attrition rate, at least 142 stone management subjects with Tria™ stent procedures 
where stents indwell at least 12 hours are required. 
11.1.1.3. Statistical Methods 
The hypotheses above will be evaluated based on the two-sided 95% exact Clopper-Pearson 
confidence interval for the proportion of stented ureters with technical success. Only stents 
placed at least 12 hours will be included in the analysis. If the lower bound of the confidence 
interval exceeds 85%, the alternative hypothesis will be demonstrated. Sensitivity analysis to 
missing data will be performed using tipping-point analysis.  
In addition, a Generalized Estimating Equation (GEE) model will be used to estimate the 
technical success rate to account for within-subject correlation due to bilateral stent 
placement if applicable. 
Descriptive statistics including 95% confidence intervals will be utilized to summarize the 
technical success rates for the non-stone management subjects treated with Tria™ stents 
respectively.  
For non Tria™ ureteral stents in the study, the technical success rates will be summarized by 
descriptive statistics including 95% confidence intervals by indication (i.e. stone 
management, benign obstruction, malignant obstruction, ureteral dysfunction, bladder cancer, 
and other as applicable) respectively for each device type.  Only stents placed at least 12 
hours will be included in the analysis.   
11.1.2.  Primary Safety Endpoint - SADE 
The primary safety endpoint is serious adverse device effect related to the study stent(s) 
implanted.  

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11.1.2.1. Hypotheses 
There is not a pre-specified pass/fail hypothesis for this endpoint.  
11.1.2.2. Statistical Methods 
Rates of serious adverse device effects will be summarized using descriptive statistics (event 
counts, proportion of subjects with a SADE) for each study stent type implanted respectively.  
In addition, all AEs will be summarized by relatedness to procedure and/or device for each 
study stent type implanted respectively.  
 
11.2. General Statistical Methods 
11.2.1. Analysis Sets 
The Intent-to-Treat (ITT) subject population includes all subjects who provide written 
informed consent to be enrolled into the study, and have the stent placement procedure 
initiated.  
The As Treated (AT) Population includes all subjects for whom the stent placement is 
completed. 
The Per Protocol (PP) population includes all subjects in the AT Population who meet all 
eligibility criteria.  
The endpoint analyses will be performed for the ITT population. The AT and PP populations 
will be evaluated as sensitivity analyses for the primary efficacy endpoint and the safety 
outcomes will also be assessed using the AT population. 
11.2.2. Control of Systematic Error/Bias 
All subjects will be treated according to the directions in the Operating Manual and 
IFU/DFU. 
The primary efficacy endpoint analysis based on the exact Clopper-Pearson confidence 
interval is specified to be conservative in order to avoid bias towards demonstrating the 
primary hypothesis (i.e., achieving the performance goal) of the study. Furthermore, the 
potential of bias from missing data for the primary efficacy endpoint will be assessed through 
tipping point analysis.  
11.2.3. Number of Subjects per Investigative Site 
The study will be conducted at up to 35 sites. Sites will be encouraged to enroll a minimum 
of 10 subjects. 

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11.3. Data Analyses 
The analyses will include the available cases unless specified otherwise. Presentation of 
summary statistics for continuous variables will include N, mean, median, standard 
deviation, minimum, and maximum values. For categorical variables, the number and 
percentage under each category will be presented. 
11.3.1. Other Endpoints/Measurements  
11.3.1.1. Additional Endpoint 1 - QoL 
To evaluate the change in quality of life as measured by Patient-Reported Outcomes 
Measurement System (PROMIS®) at Stent Removal Visit compared to Index Procedure. 
 
The endpoints are Pain Interference assessed by the PROMIS Short Form v1.0 - Pain 
Interference 6b instrument, and Pain Intensity assessed by the PROMIS Scale v1.0 – Pain 
Intensity 3a scale.   
11.3.1.1.1  Statistical Methods 
Descriptive statistics including 95% confidence intervals will be used to summarize the pain 
interference and pain intensity at Index Procedure, and Stent Removal Visit along with 
change from Index Procedure for each ureteral study stent type implanted respectively 
(excluding urinary diversion stents). 
11.3.1.2. Additional Endpoint 2 - Ureteral Stent Migration 
The endpoint is ureteral stent migration defined as any post procedure movement of the stent 
(i.e., either proximally towards the kidney or distally towards the bladder or complete distal 
migration) from its implant location; confirmed via imaging where necessary.  Note: 
Movement of a stent by external force or by inadvertent pulling is not considered a stent 
migration.  
11.3.1.2.1  Statistical Methods 
Descriptive statistics including 95% confidence intervals will be used to summarize the 
ureteral stent migration rate for each study stent type implanted respectively. 
11.3.2. Interim Analyses  
No formal interim analyses are planned for the purpose of stopping the study early for 
declaring effectiveness or for futility. 

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11.3.3. Subgroup Analyses 
The study efficacy and safety endpoints will be summarized by indication (i.e. stone 
management, benign obstruction,  malignant obstruction, ureteral dysfunction, bladder 
cancer, and other as applicable) for each study stent type respectively.  
11.3.4. Justification of Pooling 
Fisher’s Exact test or Chi-squared test will be applied to evaluate the homogeneity of the 
technical success rates by indication (i.e. stone management, benign obstruction, malignant 
obstruction, ureteral dysfunction, bladder cancer, and other as applicable) across the study 
sites for each study stent type implanted respectively.  
11.3.5. Multivariable Analyses 
There are no planned multivariable analyses.  
11.3.6. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
12. 
Health Economics Outcomes 
No formal health economics analysis is currently planned to be completed as part of this trial 
study. An economics analysis may be executed after the completion of this trial study. The 
primary safety endpoints may be used to calculate the costs associated with treating reported 
adverse events.  
 
13. 
Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata EDC System. All 
changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the sponsor or its representative. The associated Rave software and database have 
been designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 

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The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the Medidata EDC system 
and will be issued to the site for appropriate response. Site staff will be responsible for 
resolving all queries in the database. 
All access to the clinical database will be changed to “Read only” after all data is either 
“Hard Locked” or “Entry Locked”. Once acceptance of the final report or finalization of 
publications (as applicable) is received, final database storage and archiving activities can 
begin. Once all of the closeout activities are completed a request to IT is submitted to have 
the “Database Locked” or Decommissioned and all database access revoked. 
13.2. Questionnaires 
Paper questionnaires that are completed by the subject are transcribed into the EDC database 
by the site staff. For follow-up visits completed remotely, the paper questionnaires will be 
answered by the subject and responses documented on the paper questionnaire by the 
delegated research team member.  
13.3. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain all 
essential study documents and source documentation that support the data collected on the 
study subjects in compliance with applicable regulatory requirements.   
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or 
his/her designee withdraws responsibility for maintaining these essential documents, custody 
must be transferred to an individual who will assume responsibility and BSC must receive 
written notification of this custodial change. Sites are required to inform Boston Scientific in 
writing where paper or electronic files are maintained in case files are stored off site and are 
not readily available. 
14. 
Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC/REB, and the regulatory authority if applicable, of any 
deviation from the investigational plan to protect the life or physical well-being of a subject 
in an emergency, and those deviations which affect the scientific integrity of the clinical 
investigation. Such notice shall be given as soon as possible, but no later than 5 working days 

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after the emergency occurred, or per prevailing local requirements, if sooner than 5 working 
days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC (Electronic Data 
Capturing) system.  Sites may also be required to report deviations to the IRB/EC/REB, and 
the regulatory authority, per local guidelines and national/government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including IRB/EC/REB notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
15. 
Compliance 
15.1. Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site 
can be “Authorized to Enroll,” the investigational site must enter into a Clinical Study 
Agreement with the sponsor that details the financing of the study as well as the rights and 
obligations of the investigational site and the investigator. This study will be conducted in 
accordance with applicable FDA regulations (21 CFR 50, 54, 56), ISO 14155: Clinical 
Investigation of Medical Devices for Human Subjects, ICH Good Clinical Practice,  ethical 
principles that have their origins in the Declaration of Helsinki, and applicable individual 
country laws and regulations. Applicability of the above principles have been reviewed for 
this post-market observational clinical investigation and justifications for ISO 14155 
exemptions noted in the appropriate sections. 
The study shall not begin until the required approval/favorable opinion from the 
IRB/EC/REB and/or regulatory authority has been obtained, if appropriate. Also, the study 
shall not begin prior to issuance of the site Authorization to Enroll, as provided by the 
sponsor. Any additional requirements imposed by the IRB/EC/REB or regulatory authority 
shall be followed, if appropriate.  
Japan only: Clinical Trial Organization will be documented and available on a separate 
document. 
15.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation 
plan, the spirit of ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC/REB, and prevailing 
local and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  

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• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• Provide his/her qualifications (all investigators including sub-investigators) and 
experience to assume responsibility for the proper conduct of the study and that of key 
members of the site team through up-to-date curriculum vitae or other relevant 
documentation and disclose potential conflicts of interest, including financial, that may 
interfere with the conduct of the clinical study or interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 
• Report to sponsor, per the protocol requirements, all reportable events. 
• Report to the IRB/EC/REB and regulatory authorities any SAEs and device deficiencies 
that could have led to a SADE and potential/USADE or UADE, if required by applicable 
laws or regulations or this protocol or by the IRB/EC/REB, and supply BSC with any 
additional requested information related to the safety reporting of an event. 
• Allow the sponsor to perform monitoring and auditing activities and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB/EC/REB when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC/REB requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 

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• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Discuss or review questionnaire responses from subjects and subsequently report adverse 
event(s) if warranted. 
 
15.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training, are competent to perform the tasks they have been delegated and 
adequate supervision of those to whom tasks are delegated. Where there is a sub investigator 
at a site, the sub investigator should not be delegated the primary supervisory responsibility 
for the site. The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of the clinical study.  
15.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC/REB for the clinical investigation before recruiting subjects and implementing all 
subsequent amendments, if required. 
A copy of the written IRB/EC/REB and/or competent authority (CA) approval of the 
protocol (or permission to conduct the study) and ICF, must be received by the sponsor 
before recruitment of subjects into the study. Prior approval must also be obtained for other 
materials related to subject recruitment or which will be provided to the subject. 

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Any amendment to the protocol will require review and approval by the IRB/EC/REB before 
the changes are implemented to the study.  All changes to the ICF will be IRB/EC/REB 
approved; a determination will be made regarding whether a new ICF needs to be obtained 
from participants who provided consent, using a previously approved ICF.  
Annual IRB/EC/REB approval and renewals will be obtained throughout the duration of the 
study as required by applicable local/country laws or regulations or IRB/EC/REB 
requirements. Copies of the study reports and the IRB/EC/REB continuance of approval must 
be provided to the sponsor.  
15.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations. Only authorized BSC personnel and/or a BSC representative 
including, but not limited to Contract Research Organization (CRO), will have access to this 
information. Authorized regulatory personnel have the right to inspect and copy all records 
pertinent to this study. Study data collected during this study may be used by BSC for the 
purposes of this study, publication, and to support future research and/or other business 
purposes, such as overseeing and improving the performance of its device, new medical 
research and proposals for developing new medical products and procedures. All data used in 
the analysis and reporting of this study or shared with a third-party researcher will be without 
identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes. 
15.5. General Data Protection Regulations (GDPR) 
Data collected from clinical trial data subjects are considered “personal data” (including 
sensitive personal data in some cases). The protection of clinical trial subject personal data and 
compliance with privacy, data protection laws and regulations are of critical importance to 
BSC. Data collection has been carefully considered for this study and has been restricted to the 
strict essentials with a clear, specific and detailed purpose to mitigate the risk and the impact 
of data breach and to comply with data privacy laws (including but not limited to HIPAA and 
GDPR). Section 10 of the protocol defines the data that need to be collected to fulfill the 
objectives of the clinical study. 
 
Personal data collected by Boston Scientific includes, but is not limited to:  
• Geographic data (site name)  
• Important Dates  
o Informed consent date  
o Age at the time of study enrollment 
o Procedure date  
o Adverse event start/end date  
o Hospitalization admission/discharge date  

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o Subject visit dates  
 
The purposes of the personal data processing will be carefully defined within the informed 
consent form. Personal data will not be used for a purpose other than the one stated in the 
informed consent provided to the subjects. Personal data shall not be disclosed, made available, 
or otherwise used, processed, transferred, or stored for purposes other than those specified in 
the informed consent form, except: 
• with the consent of the data subject; or 
• processing is necessary for compliance with a legal obligation.  
 
15.5.1. Transparency 
BSC must only collect personal data by fair and lawful means. BSC must be transparent and 
open with individuals about how BSC collects and uses personal data, with whom BSC 
shares it, and where it may be processed. 
For this transparency principle, BSC must provide information to our health care providers 
and their study subjects about the purpose for collecting their personal data; who will have 
access to the data and to whom it may be shared, if it will be accessed or transferred to 
another country; and who to contact with questions or requests. 
15.5.2. Rights to Data Subjects 
In GDPR, a data subject is any living individual to whom the personal data relates. A data 
subject includes study subjects. Data subjects shall have the right to:  
• obtain from BSC confirmation of whether BSC has data relating to the individual; 
• have data relating to them communicated: 
o within a reasonable time (within 30 days from receipt of request, extendable if 
complicated or unclear request); 
o at a charge, if any, that is not excessive; 
o in a reasonable manner; and 
o in a form that is readily intelligible to the individual; 
• be given reasons if a request made under subparagraphs (a) and (b) is denied, and to be 
able to challenge such denial; 
• challenge data relating to the individual and, if the challenge is successful, to have the 
data erased, rectified, completed, or amended. During the period of such challenge, the 
individual can require that access to the data be restricted; 
• "opt out"/oppose that their personal data are used for marketing purposes; and, 
• when requested, BSC must also communicate any rectification or erasure of personal 
data or restriction of processing to each recipient to whom the personal data have been 
disclosed, unless this proves impossible or involves disproportionate effort. 
These rights will also be listed in the subject informed consent form.  

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15.6. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
16. 
Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. The sponsor will put a plan in place to document the 
specific monitoring requirements. In addition, the clinical research monitor verifies that study 
records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site or remote monitoring visits or 
audits and that sufficient time is devoted to the process. 
17. 
Potential Risks and Benefits 
17.1. Instructions/Directions for Use 
Please refer to the Instructions/Directions for Use (IFU/DFU) for an overview of anticipated 
adverse (device) effects and risks associated to the commercial device(s).   
17.2. Risks associated with Participation in the Clinical Study 
The BSC ureteral stents and urinary diversion stents are commercially available devices. 
None of the procedures associated with this study fall outside of standard of care procedure. 
Therefore, there are no foreseen additional risks associated with the device implant 
procedure, testing, or withdrawal from the study.  
17.3. Possible Interactions with Concomitant Medical Treatments, if applicable 
Please refer to the individual ureteral stent IFU/DFU for the interactions with medications 
recommended per the post procedural medication regime.   
17.4. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
IFU/DFU, performing procedures in the appropriate hospital environment, adherence to 
subject selection criteria, close monitoring of the subject's physiologic status during research 

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procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
17.5. Anticipated Benefits 
The benefits of having any ureteral stent include the facilitation of drainage from the kidney, 
or kidney to the bladder.  Ureteral stents may also aid the ureter as it heals after procedural 
intervention.  The information gathered from this study may help physicians worldwide 
develop a better understanding of the safety and efficacy of ureteral stents, literature reported 
stent related pain and QoL associated with stent indwell time.  
 
18. 
Safety Reporting 
18.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories from the time of index procedure to end of the study: 
• Serious Adverse Device Effects  
• Serious Adverse Events related to the Index Procedure (inclusive of Study Stent 
Implant Procedure) and/or Study Stent Removal Procedure  
• Serious Adverse Events resulting in death (regardless of relatedness to the study 
device and/or procedure, i.e., Index, Stent Implant, and/or Stent Removal)  
• Device Deficiencies 
• Adverse Device Effects  
• Adverse Events related to the Index Procedure (inclusive of Study Stent Implant 
Procedure) and/or Study Stent Removal Procedure. 
Adverse events to be reported include both anticipated and expected post procedural events 
(such as pain, hematuria, urgency, frequency, urinary leakage and ureteral strictures, etc.) in 
addition to any other unanticipated or unexpected events. 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether an event fits one of the above categories, or if the event cannot be 
isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any reportable events, experienced by the study subject from the time of index procedure to 
end of the study, must be recorded on an eCRF.  
It is the responsibility of investigator or designee to update eCRFs with new findings/updates 
in relation to already reported events as soon as they become aware.  

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Underlying diseases and chronic conditions are not reported as AEs unless there is an 
increase in severity or frequency during the investigation. Death should not be recorded as an 
AE but should only be reflected as an outcome of one (1) specific SAE (see Table 18.2 for 
safety definitions). 
Refer to IFU/DFU for the known risks associated with the commercial device(s). 
 
18.2.  
Definitions and Classification 
Safety definitions are provided in Table 18.2. Administrative edits were made on the safety 
definitions from applicable regulations and guidance including (but not limited to) 21 CFR 
Part 812, ISO 14155 and EU MDR 2017/745/MDCG 2020-10/1 Guidance on Safety 
Reporting in Clinical Investigations for clarification purposes. 
 
Table 18.2: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1  
 
 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, in the context of a clinical investigation, 
whether related to the study medical device and whether anticipated or 
unanticipated. 
NOTE 1: This includes events related to the study medical device or 
comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the study medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Adverse event related to the use of the study medical device. 
NOTE 1: This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, 
the installation, the operation, or any malfunction of the study medical 
device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the study medical device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1   
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons 
as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 
including chronic diseases, or 

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Table 18.2: Safety Definitions 
Term 
Definition 
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
c) foetal distress, fetal death, or a congenital abnormality or birth defect 
including physical or mental impairment. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without a serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
Unanticipated Serious 
Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current risk assessment. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in 
the risk assessment. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  
NOTE 1: Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including 
labelling. 
NOTE 2: This definition includes device deficiencies related to the device 
under study. 
Serious Health Threat  
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that indicates an 
imminent risk of death or a serious deterioration in the health in subjects, 
users or other persons, and that requires prompt remedial action for other 
subjects, users or other persons. 
Note 1: This would include events that are of significant and unexpected 
nature such that they become alarming as a potential serious health hazard 
or possibility of multiple deaths occurring at short intervals. 

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Table 18.2: Safety Definitions 
Term 
Definition 
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE 
classification purposes: 
Hospitalizations  
Pre-planned, protocol-specified admission related to the clinical study (e.g. 
procedure required by protocol)Note:  
Hospitalization include: 
 
• 
New, unplanned admission for evaluation or treatment of an event 
occurring following stent placement,  
• 
Admitted to hospital for greater than or equal to 24 hrs 
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient admission  
Note: although an emergency room visit does not itself meet the 
definition for hospitalization, it may meet other serious criteria 
(e.g. medical or surgical intervention to prevent permanent 
impairment or damage) 
• 
elective and pre-planned treatment/surgery for a pre-existing 
condition that is documented in the subject’s record at the time of 
consent/enrollment 
• 
admission for social reasons and/or respite care in the absence of 
any deterioration in the subject’s general condition (e.g. subject is 
homeless, caregiver relief) 
Prolongation of 
hospitalization  
In-patient admission to the hospital that is prolonged beyond the expected 
standard duration for the condition under treatment. 
Note: new adverse events occurring during the hospitalization are evaluated 
to determine if they prolonged hospitalization or meet another SAE criteria. 
 
18.3. Relationship to Device(s), Index Procedure (including Study Stent Implant 
Procedure), and/or Study Stent Removal Procedure 
The Investigator must assess the relationship of the reportable AE to the device, and/or Index 
procedure (including Study Stent Implant Procedure), and/or the study stent removal 
procedure. See criteria in Table 18.3 . 
 

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Table 18.3: Criteria for Assessing Relationship of Study Device, Index Procedure 
(including Study Stent Implant Procedure), and Study Stent Removal Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
Ref: MDCG 2020-10/1 
 
Relationship to the device, comparatoror procedures can be excluded when: 
- the event has no temporal relationship with the use of the study device or the 
procedures related to the use of the study device; 
- the serious event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site, or an organ  that cannot be affected by the device 
or procedure;  
- the serious event can be attributed to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment 
or other risk factors); 
- the event does not depend on a false result given by the study device used for 
diagnosis, when applicable; 
- In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the serious 
event. 
Possibly Related 
Ref: MDCG 2020-10/1 
 
The relationship with the use of the study device or comparator, or the relationship 
with procedures is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases where relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
Probably Related 
Ref: MDCG 2020-10/1 
 
The relationship with the use of the study device, or comparator, or the relationship 
with procedures seems relevant and/or the event cannot be reasonably explained by 
another cause. 

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Table 18.3: Criteria for Assessing Relationship of Study Device, Index Procedure 
(including Study Stent Implant Procedure), and Study Stent Removal Procedure to 
Adverse Event 
Classification 
Description 
Causal Relationship 
Ref: MDCG 2020-10/1 
 
The serious event is associated with the study device, comparator or with 
procedures beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with the study device use/application or 
procedures; 
- the event involves a body-site or organ that 
-the study device or procedures are applied to; 
-the study device or procedures influence; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the study device used for diagnosis, 
when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 
 
18.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 18.4. These 
events should be reported via electronic data capture (EDC) system and may be reported via 
phone, or email if the EDC system is unavailable. The paper AE Notification Form or Device 
Deficiency Notification Form should be used to report AEs and Device Deficiencies as 
applicable during this time when the EDC system is unavailable. 
 
 
 

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Table 18.4: Investigator Reporting Timelines 
Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(EU MDR 2017/745, MDCG 2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
Unanticipated Adverse 
Device Effect / Unanticipated 
Serious Adverse Device 
Effect 
 
NOT APPLICABLE; post 
market non-interventional 
study; standard of care 
Complete AE eCRF page 
with all available new and 
updated information. 
• 
Within 1 business day of first 
becoming aware of the event. 
• 
Terminating at the end of the study. 
 
Provide all relevant source 
documentation (deidentified/ 
pseudonymized) 
for reported event. 
• 
Upon request of sponsor. 
Serious Adverse Event  
Complete AE eCRF page 
with all available new and 
updated information.  
• 
Within 10 calendar days after 
becoming aware of the event or as per 
local/regional regulations.  
• 
Reporting required through the end of 
the study.  
Provide all relevant source 
documentation (de-identified/ 
pseudonymized) for reported 
event as requested.  
• 
When documentation is available  
• 
Upon request of Sponsor 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
• 
Within 3 calendar days of first 
becoming aware of the event or as per 
local/regional regulations. 
• 
Reporting required through the end of 
the study. 
Provide all relevant source 
documentation (de-identified/ 
pseudonymized) for reported 
event.  
• 
When documentation is available  
• 
Upon request of sponsor 
Device Deficiencies (including 
but not limited to malfunctions, 
use errors, andinadequacies in 
information supplied by the 
manufacturer, including 
labeling) 
Note:  Any Device Deficiency 
that might have led to a serious 
adverse event if appropriate 
action had not been taken, 
intervention had not occurred, 
circumstances had been less 
fortunate is considered a 
reportable event. 
Complete DeviceDeficiency 
CRF with all available new 
and updated information.  
• 
Within 3 calendar days of first 
becoming aware of the event.  
• 
Reporting required through the end of 
the study. 
Provide all relevant source 
documentation (de-identified/ 
pseudonymized) for reported 
event. 
• 
Upon request of sponsor  

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Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(EU MDR 2017/745, MDCG 2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
Index Procedure (including 
Study Stent Implant Procedure) 
Related Adverse Events, 
Study Stent Removal 
Procedure Related Adverse 
Events and Adverse Device 
Effects  
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device.  
• 
In a timely manner (e.g. recommend 
within 30 business days) after 
becoming aware of the information. 
• 
Reporting required through end of 
study.  
Provide all relevant source 
documentation (de-identified/ 
pseudonymized) for reported 
event as requested.  
• 
 Upon request of sponsor 
18.5. Study Device Deficiencies  
Device deficiencies, for BSC Ureteral Stents and BSC Urinary Diversion Stents will be 
documented and reported to BSC. Device deficiencies should also be documented in the 
subject’s source records. 
Stent migrations and stent dislodgements should be reported as potential device deficiencies.  
Stent migration is defined as any post procedure movement of the stent (either proximally 
towards the kidney or distally towards the bladder or complete distal migration) from its 
implant location; confirmed via imaging where necessary.  
Stent dislodgement is defined as removal of the stent during the planned indwell time by 
external force or inadvertent pulling. 
Device deficiencies are not adverse events. However, an adverse event that results from a 
device deficiency, should be recorded as an adverse event on the appropriate eCRF. 
18.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators, IRBs/ECs/REBs and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC/REB, and regulatory 
authorities of SAEs as required by local/regional regulations. 
18.7. Subject Death Reporting  
A subject death that occurs during the study should be reported to Boston Scientific as soon 
as possible and, in any event, within three (3) calendar days of site notification. The site’s 

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IRB/EC/REB must be notified of any deaths in accordance with that site’s IRB/EC/REB 
policies and procedures.  
Notification of death should include a narrative that provides detailed information describing 
the circumstances surrounding the death. The details listed below should be addressed in the 
death narrative, for BSC to understand the circumstance surrounding the death: 
• Date of death 
• Immediate cause of death  
• Whether the death was related to the study device or procedure 
• Any other circumstances surrounding the death  
• Investigator or sub-investigator signature and date  
Also submit the following documentation:  
• If the Subject expired in the hospital:  
o A copy of the medical records for that admission (e.g., H & P, consults, 
test results, operative reports, and/or progress notes from the hospital 
chart)  
o Death certificate (if available)  
o Autopsy report (if applicable)  
• If the Subject expired outside of the hospital (e.g., home):  
o A copy of the most recent clinic visit (if not already submitted to Boston 
Scientific)  
o Death certificate (if available)   
o Autopsy report (if applicable)  
The Independent Medical Reviewer will review information regarding subject deaths. 
19. 
Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any study devices, study-
required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO) and approved by the site’s IRB/EC/REB, or central IRB, if 
applicable. 

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Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC/REB.  Any modification requires acceptance from BSC prior to 
use of the form.  The ICF must be in a language understandable to the subject and if needed, 
BSC will assist the site in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC/REB approval prior to their use.  Privacy language shall be included 
in the body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct 
the process,  
• include a description of all aspects of the clinical study that are relevant to the 
subject’s decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or 
his/her legal representative, 
• provide ample time for the subject to consider participation and ask questions 
if necessary, 
• ensure important new information is provided to new and existing subjects 
throughout the clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory 
authority according to their requirements (e.g., FDA requirement is within 5 working days of 
learning of such an event). Any violations of the informed consent process must be reported 
as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC/REB), as 
appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 

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following annual review by the IRB/EC/REB. The new version of the ICF must be approved 
by the IRB/EC/REB. Acceptance by Boston Scientific is required if changes to the revised 
ICF are requested by the site’s IRB/EC/REB. The IRB/EC/REB will determine the subject 
population to be re-consented. 
A Screening/Enrolment Log will be maintained to document select information about 
candidates who fail to meet the general or "other specific" entry criteria. 
20. 
Committees 
20.1. Safety Monitoring Process 
Personnel from the BSC Medical Safety and Safety Trial Operations group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source documents and other data information. The BSC Medical Safety and Safety 
Trial Operations team  include a physician Medical Director and individuals with subject 
matter expertise to evaluate and classify the events into the categories outlined above.  
20.2. Independent Medical Reviewer 
A single Independent Medical Reviewer (IMR) with pertinent expertise, will review and 
adjudicate relevant events reported by study investigators only for subjects who have 
received TriaTM Firm or TriaTM Soft stents. The IMR will also review and adjudicate all 
imaging and deaths reported by study investigators, regardless of stent type. The IMR will 
review a safety event dossier, which may include copies of subject source documents 
provided by study sites. 
IMR responsibilities, qualifications, membership, and procedures are outlined in the IMR 
Charter. 
20.3. Steering Committee 
A Steering committee composed of recognized key opinion leaders/physicians in the field of 
Urology will be convened. The Steering Committee for the study will provide the following:  
• Oversight of protocol development, data integrity, and timely dissemination and 
publication of the study results, and 
• Prepare for, participate in, and/or facilitate investigator meetings, study Steering 
committee meetings or any other meetings at BSC’s request, providing, among 
other things, leadership, protocol insight, and  
• Serve as a general spokesperson for the study through word of mouth and podium 
presence at major clinical conferences, symposia, and various educational 
meetings, and 

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• Prepare for, participate in, and/or facilitate scheduled teleconferences, webcasts, 
and one-on-one contact with site investigators to discuss enrolment issues, study 
progress, and/or any new or pertinent study information, and 
• Advise and assist BSC with the data preparation and analysis process. 
 
21. 
Suspension or Termination 
21.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated IRBs/ECs/REBs, and regulatory authorities, as applicable, 
will be notified in writing in the event of study termination. 
21.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following: 
• Suspicion of an unacceptable risk, including serious health threat. In this case, the 
sponsor shall suspend the clinical investigation while the risk is assessed. The sponsor 
shall terminate the clinical investigation if an unacceptable risk which cannot be 
controlled is confirmed. 
• Instructions by the IRB/EC/REB or regulatory authorities to suspend or terminate the 
clinical investigation. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue 
development/marketing of the device. 
21.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ 
EC/REB Approval 
Any investigator, or associated IRB/EC/REB or regulatory authority may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs/REBs, and regulatory 
authorities, as applicable, will be notified in writing in the event of these occurrences. 
21.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination, a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB/EC/REB and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  

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In the event an IRB/EC/REB terminates participation in the study, participating investigators, 
associated IRBs/ECs/REBs, and regulatory authorities, as applicable, will be notified in 
writing. Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
devices, if supplied by Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
21.4 Criteria for Suspending/Terminating a Study Site  
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled for a period beyond 3 months 
after site initiation, or if the site has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The IRB/EC/REB and regulatory authorities, as applicable, will 
be notified. Study participants will be contacted, as applicable, and be informed of changes to 
study visit schedule. 
 
22. 
Study Registration and Results 
22.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 
22.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC/REB and regulatory 
authorities, as applicable in accordance with the Boston Scientific Policy and local 
requirements.  As applicable an abbreviated Clinical Investigation Report will be made 
available on a publicly accessible database. 

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23. 
Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC will submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific adheres to the Contributorship Criteria set forth in the 
Uniform Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed:  
• All authorship and contributorship requirements as described above must be 
followed. 
• BSC involvement in the publication preparation and the BSC Publication 
Policy should be discussed with the Coordinating Principal Investigator(s) 
and/or Executive/Steering Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding 
publication content, review, approval, and submission.  
The data, analytic methods, and study materials for this clinical trial may be made available 
to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
24. 
Reimbursement and Compensation for Subjects 
24.1. Subject Reimbursement 
Subjects may be compensated for participation in the study, in accordance with pertinent 
country laws and regulations and per the study site’s regulations.   
 
24.2. Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health 
injury for study subjects, if required by applicable law.  
 
 

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25. 
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Burgess, N. A. (2013, June). Multi-length or 24 cm ureteric stent? A multicentre 
randomised comparison of stent-related symptoms using a validated questionnaire. 
BJU International, 111(7), 1099-1104. 
Chen, I.-H., Tsai, J.-Y., Yu, C.-C., Wu, T., & Lin, J.-T. (2013, October 28). Ureteroscope-
assisted double-J stenting following laparoscopic ureterolithotomy. The Kaohsiung 
Journal of Medical Sciences, 30(5), 243-247. 
El-Faqih SR, S. A. (1991). Polyurethane internal ureteral stents in treatment of stone patients: 
morbidity related to indwelling times. J Urology, 146(6):1487-91. 
Grasso, R. F., Faiella, E., Cazzato, R. L., Lippi, G., Del Vescovo, R., Giurazza, F., . . . Zobel, 
B. B. (2013). Retrograde fluoroscopy-guided trans-urethral exchange of ureteral 
stents: Comparison of direct grasping vs. modified snare. Indian Journal of Radiology 
and Imaging, 23(4), 347-350. 
Koprowski, C., Kim, C., Modi, P. K., & Elsamra, S. E. (2016, July). Ureteral Stent-
Associated Pain: A Review. Journal of Endourology, 30(7), 744-753. 
Lingeman, J., Preminger, G., Goldfischer, E., & Krambeck, A. (2009). Assessing The Impact 
Of Ureteral Stent Design On Patient Comfort. J Urology, 2581-2587. 
Mohan-Pillai, K., Keeley, F. X., Maussa, S. A., Smith, G., & Tolley, D. A. (1999, June). 
Endourological Management of Severly Encrusted Ureteral Stents. Journal of 
Endourology, 13(5), 377. 
Ozgur, B. C., Ekici, M., Yuceturk, C. N., & Bayrak, O. (2013, December). Bacterial 
colonization of double J stents and bacteriuria frequency. The Kaohsiung Journal of 
Medical Sciences, 29(12), 658-661. 
Satyanand, T., Patel, C. J., Patel, J., Tarun, P., & Soniya. (2012). Review on Kidney Stones. 
Journal of Biomedical and Pharmaceutical Research, 1(3). 
Scarneciu, I., Lupu, S., Pricop, C., & Scarneciu, C. (2015). Morbidity and impact on quality 
of life in patients with indwelling ureteral stents: A 10-year clinical experience. Pak J 
Med Sci, 522-526. 
Torricelli, F. C., De, S., Hinck, B., Noble, M., & Monga, M. (2014, February). Flexible 
Ureteroscopy With a Ureteral Access Sheath: When to Stent? Urology, 83(2), 278-
281. 
Türk, C., Petřík, A., Sarica, K., Seitz, C., Skolarikos, A., Straub, M., & Knoll, T. (2016, 
March). EUA Guidelines on Interventional Treatment for Urolithiasis. European 
Urology, 69(3), 475-482. 
Ziemba, J. B., & Matlaga, B. R. (2017, September). Epidemiology and economics of 
nephrolithiasis. Investigative and Clinical Urology, 58(5), 299-306. 
 
 
 

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26. 
Abbreviations and Definitions  
26.1. Abbreviations 
Abbreviations are shown in Table 26.1.   
Table 26.1: Abbreviations 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
AT 
As Treated 
BSC 
Boston Scientific Corporation 
CA 
Competent Authority 
CCGs 
Case Report Form Completion Guidelines 
DFU 
Directions for Use 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture  
GDPR 
Global Data Protection  
HIPAA 
Health Information Portability and Accountability Act 
ICF 
Informed Consent Form 
IFU 
Instructions For Use 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
PP 
Per Protocol  
QoL 
Quality of Life 
REB 
Research Ethics Board 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SOC 
Standard of Care 
UAS 
Ureteral Access Sheaths 
UDS 
Urinary Diversion Stent 
US 
Ureteral Stent 
 
 
 

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26.2. Definitions 
Terms are defined in Table 26.2.  
Table 26.2: Definitions 
Term 
Definition 
Adverse Device Effect  
See Table 18.2-1, Safety Definitions 
Adverse Event 
See Table 18.2-1, Safety Definitions 
As Treated 
All subjects for whom placement of the device is completed. 
Consent Ineligible 
A subject who has signed the ICF but is found to not meet eligibility criteria. 
These subjects can still receive the BSC Ureteral Stent per standard of care 
treatment, but do not count toward enrollment. The subjects will be exited and 
will not undergo any study related procedures once their ineligibility has been 
determined.   These subjects do not count toward enrollment. 
Data Controller 
In GDPR: The entity which determines the purposes (why the entity needs to 
process data) and means (database managed through a software, hard copy files, 
centralized database) of personal information processing. 
Data Processor 
In GDPR: The person or entity processing the data on behalf and according to 
the instructions of the data controller. An entity which uses an external data 
processor must ensure that, in the contract, its data processor offers adequate 
guarantees to ensure the security and confidentiality of the data communicated. 
Data Subject 
In GDPR: Any living individual to whom the personal data relates. Examples of 
data subjects in this study are physicians and subjects. 
Deviation (Clinical 
Protocol) 
A departure from the requirements established in the clinical trial protocol (e.g., 
inclusion/exclusion criteria; visit windows, required procedures, and any 
specified consenting process requirements). 
Exited Prior to Procedure 
A subject who signs the informed consent, meets eligibility criteria but then 
does not undergo have the index study procedure initiated (first incision) or 
receive the study device. The original ICF and screening documentation for 
these patients should be maintained in the site’s files. There are no follow-up 
requirements and these subjects do not count toward enrollment. Any data 
collected prior to procedure is not included in statistical analyses. These 
subjects do not count toward enrollment. 
General Data Protection 
Regulation (GDPR) 
The General Data Protection Regulation (GDPR) is a European law that will 
govern how companies (whether EU-based or not) use personal data. 
Identifiers 
“Identifiers” are personal data that can be used alone or in combination with 
other identifiers to identify an individual.  
Index Procedure 
Describes the entirety of the procedure in which the stent is implanted; includes 
ureteral access sheath insertion, scoping, irrigation, laser lithotripsy, basketing, 
stent implant, etc. 
Independent Medical 
Reviewer 
An independent practitioner with trial relevant therapeutic expertise that 
reviews and adjudicates important endpoints and relevant adverse events 
reported by study investigators. 
Intent-To-Treat 
A subject who signs the informed consent, meets eligibility criteria, and for 
whom the index procedure is initiated.  
Minimal Risk 
The probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered 
in daily life or during the performance of routine physical or psychological 
examinations or tests. 

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Table 26.2: Definitions 
Term 
Definition 
Monitoring 
EN ISO 14155Act of overseeing the progress of a clinical investigation and to 
ensure that it is conducted, recorded, and reported in accordance with the CIP, 
written procedures, this International Standard, and the applicable regulatory 
requirements 
ICH E6 1.38 -  The act of overseeing the progress of a clinical study and of 
ensuring that it is conducted, recorded, and reported in accordance with the 
protocol, Standard Operating Procedures (SOPs), GCP, and the applicable 
regulatory requirement(s). 
FDA Guidance - Generally refers to the methods used by sponsors of 
investigational studies, or CROs delegated responsibilities for the conduct of 
such studies, to oversee the conduct of and reporting of data from clinical 
investigations, including appropriate investigator supervision of study site staff 
and third-party contractors. 
Multi-center study 
A clinical trial conducted according to a single protocol but at more than one 
site, and therefore carried out by more than one investigator. 
Patient-Reported Outcome 
(PRO) 
A measurement based on a report that comes directly from the patient (i.e., 
study subject) about the status of a patient’s health condition without 
amendment or interpretation of the patient’s response by a clinician or anyone 
else. A PRO can be measured by self-report or by interview provided that the 
interviewer records only the patient’s response. 
Per Protocol 
All subjects in the As Treated Population who have no major protocol 
deviations. 
Personal Data  
GDPR defines “Personal data” to be any information relating to an identified or 
identifiable natural person (‘data subject’); an identifiable natural person is one 
who can be identified, directly or indirectly, in particular by reference to an 
identifier such as a name, an identification number, location data, an online 
identifier or to one or more factors specific to the physical, physiological, 
genetic, mental, economic, cultural or social identity of that natural person. 
Point of Enrollment 
Time at which subject has signs and dates the informed consent (ICF) and 
meets the eligibility criteria.   
Processing 
Any use of personal data by BSC (or a third party on behalf of BSC), including 
data collection, data sharing, anonymization, and data storage (note the mere 
storage of data is considered as processing). 
RAVE 
Proprietary electronic data capture system for capturing, managing and 
reporting clinical study data. 
Recruitment 
Active efforts to identify subjects who may be suitable for enrollment in the 
clinical investigation. 
Sensitive Personal Data 
GDPR defines “Sensitive personal” data as a subset of Personal Data, which, 
due to their nature have been classified as deserving additional privacy and 
security protections because their processing may create a risk for an 
individual’s fundamental right and freedom. 
Serious Adverse Device 
Effect (SADE) 
See Table 18.2-1, Safety Definitions 

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Table 26.2: Definitions 
Term 
Definition 
Serious Adverse Event 
(SAE) 
See Table 18.2-1, Safety Definitions 
Site Noncompliance 
A departure from the regulations established by the relevant regulatory 
authorities. Includes all clinical site noncompliance that does not represent a 
direct deviation from the clinical trial protocol, e.g. IRB/IEC and sponsor 
reporting, device storage and accountability, staff qualifications and training, 
facilities, and equipment required to conduct the clinical trial, collection and 
documentation of data in source documents and CRFs, investigator oversight, 
etc. 
Source Data 
All information in original records of clinical findings, observations, or other 
activities in a clinical investigation, necessary for the reconstruction and 
evaluation of the clinical investigation. (Ref. ISO 14155-2011) 
Source Document 
Printed, optical or electronic document containing source data. Examples: 
Hospital records, laboratory notes, device accountability records, photographic 
negatives, radiographs, records kept at the investigation site, at the laboratories 
and at the medico-technical departments involved in the clinical investigation. 
(Ref. ISO 14155-2011) 
Study Stent Implant 
Procedure 
Describes the portion of the index procedure only inclusive of placing the stent 
Technical Success 
For Ureteral Stents: Stented kidney drains (to bladder) during the planned 
indwell time with no re-intervention due to obstruction of the stented ureters 
For Urinary Diversion Stents: Drainage followingstent placement during the 
planned indwell time with no re-intervention due to obstruction 
 
 
 

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27. 
Appendices 
27.1. Appendix 1 Ureteral Stent Product Codes 
Product Description 
UPN/Product Code 
Contour Ureteral Stent 
Contour™ Ureteral Stent 6F x 20cm 
M0061802200 
Contour™ Ureteral Stent 6F x 22cm 
M0061802210 
Contour™ Ureteral Stent 6F x 24cm 
M0061802220 
Contour™ Ureteral Stent 6F x 26cm 
M0061802230 
Contour™ Ureteral Stent 6F x 28cm 
M0061802240 
Contour™ Ureteral Stent 6F x 30cm 
M0061802250 
Contour™ Ureteral Stent 7F x 20cm 
M0061802300 
Contour™ Ureteral Stent 7F x 22cm 
M0061802310 
Contour™ Ureteral Stent 7F x 24cm 
M0061802320 
Contour™ Ureteral Stent 7F x 26cm 
M0061802330 
Contour™ Ureteral Stent 7F x 28cm 
M0061802340 
Contour™ Ureteral Stent 7F x 30cm 
M0061802350 
Contour™ Ureteral Stent 8F x 20cm 
M0061802400 
Contour™ Ureteral Stent 8F x 22cm 
M0061802410 
Contour™ Ureteral Stent 8F x 24cm 
M0061802420 
Contour™ Ureteral Stent 8F x 26cm 
M0061802430 
Contour™ Ureteral Stent 8F x 28cm 
M0061802440 
Contour™ Ureteral Stent 8F x 30cm 
M0061802450 
Contour™ Ureteral Stent 6F x 20cm 
M0061805200 
Contour™ Ureteral Stent 6F x 22cm 
M0061805210 
Contour™ Ureteral Stent 6F x 24cm 
M0061805220 
Contour™ Ureteral Stent 6F x 26cm 
M0061805230 
Contour™ Ureteral Stent 6F x 28cm 
M0061805240 
Contour™ Ureteral Stent 6F x 30cm 
M0061805250 
Contour™ Ureteral Stent 7F x 22cm 
M0061805310 

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Product Description 
UPN/Product Code 
Contour™ Ureteral Stent 7F x 24cm 
M0061805320 
Contour™ Ureteral Stent 7F x 26cm 
M0061805330 
Contour™ Ureteral Stent 7F x 28cm 
M0061805340 
Contour™ Ureteral Stent 8F x 24cm 
M0061805420 
Contour™ Ureteral Stent 8F x 26cm 
M0061805430 
Contour VL Ureteral Stent 
Contour VL™ Variable Length Ureteral Stent 4.8F x 22cm-30cm 
M0061801550 
Contour VL™ Variable Length Ureteral Stent 6F x 22cm-30cm 
M0061801560 
Contour VL™ Variable Length Ureteral Stent 7F x 22cm-30cm 
M0061801570 
Percuflex Ureteral Stent 
Percuflex™ Ureteral Stent 6F x 28cm 
M0061453630 
Percuflex™ Ureteral Stent 6F x 30cm 
M0061453640 
Percuflex™ Ureteral Stent 7F x 20cm 
M0061453690 
Percuflex™ Ureteral Stent 7F x 22cm 
M0061453700 
Percuflex™ Ureteral Stent 7F x 24cm 
M0061453710 
Percuflex™ Ureteral Stent 7F x 26cm 
M0061453720 
Percuflex™ Ureteral Stent 7F x 28cm 
M0061453730 
Percuflex™ Ureteral Stent 7F x 30cm 
M0061453740 
Percuflex™ Ureteral Stent 8F x 20cm 
M0061453790 
Percuflex™ Ureteral Stent 8F x 22cm 
M0061453800 
Percuflex™ Ureteral Stent 8F x 24cm 
M0061453810 
Percuflex™ Ureteral Stent 8F x 26cm 
M0061453820 
Percuflex™ Ureteral Stent 8F x 28cm 
M0061453830 
Percuflex™ Ureteral Stent 8F x 30cm 
M0061453840 
Percuflex Plus Ureteral Stent 
Percuflex™ Plus Ureteral Stent 4.8F x 10cm 
M0061751950 
Percuflex™ Plus Ureteral Stent 4.8F x 12cm 
M0061751960 
Percuflex™ Plus Ureteral Stent 4.8F x 14cm 
M0061751970 

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Product Description 
UPN/Product Code 
Percuflex™ Plus Ureteral Stent 4.8F x 16cm 
M0061751980 
Percuflex™ Plus Ureteral Stent 4.8F x 18cm 
M0061751990 
Percuflex™ Plus Ureteral Stent 4.8F x 20cm 
M0061752500 
Percuflex™ Plus Ureteral Stent 4.8F x 22cm 
M0061752510 
Percuflex™ Plus Ureteral Stent 4.8F x 24cm 
M0061752520 
Percuflex™ Plus Ureteral Stent 4.8F x 26cm 
M0061752530 
Percuflex™ Plus Ureteral Stent 4.8F x 28cm 
M0061752540 
Percuflex™ Plus Ureteral Stent 4.8F x 30cm 
M0061752550 
Percuflex™ Plus Ureteral Stent 6F x 20cm 
M0061752600 
Percuflex™ Plus Ureteral Stent 6F x 22cm 
M0061752610 
Percuflex™ Plus Ureteral Stent 6F x 24cm 
M0061752620 
Percuflex™ Plus Ureteral Stent 6F x 26cm 
M0061752630 
Percuflex™ Plus Ureteral Stent 6F x 28cm 
M0061752640 
Percuflex™ Plus Ureteral Stent 6F x 30cm 
M0061752650 
Percuflex™ Plus Ureteral Stent 7F x 20cm 
M0061752700 
Percuflex™ Plus Ureteral Stent 7F x 22cm 
M0061752710 
Percuflex™ Plus Ureteral Stent 7F x 24cm 
M0061752720 
Percuflex™ Plus Ureteral Stent 7F x 26cm 
M0061752730 
Percuflex™ Plus Ureteral Stent 7F x 28cm 
M0061752740 
Percuflex™ Plus Ureteral Stent 7F x 30cm 
M0061752750 
Percuflex™ Plus Ureteral Stent 8F x 20cm 
M0061752800 
Percuflex™ Plus Ureteral Stent 8F x 22cm 
M0061752810 
Percuflex™ Plus Ureteral Stent 8F x 24cm 
M0061752820 
Percuflex™ Plus Ureteral Stent 8F x 26cm 
M0061752830 
Percuflex™ Plus Ureteral Stent 8F x 28cm 
M0061752840 
Percuflex™ Plus Ureteral Stent 8F x 30cm 
M0061752850 
Percuflex™ Plus Ureteral Stent 4.8F x 22cm braided retrieval line 
M0061755510 
Percuflex™ Plus Ureteral Stent 4.8F x 24cm braided retrieval line 
M0061755520 

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Product Description 
UPN/Product Code 
Percuflex™ Plus Ureteral Stent 4.8F x 26cm braided retrieval line 
M0061755530 
Percuflex™ Plus Ureteral Stent 4.8F x 28cm braided retrieval line 
M0061755540 
Percuflex™ Plus Ureteral Stent 6F x 20cm braided retrieval line 
M0061755600 
Percuflex™ Plus Ureteral Stent 6F x 22cm braided retrieval line 
M0061755610 
Percuflex™ Plus Ureteral Stent 6F x 24cm braided retrieval line 
M0061755620 
Percuflex™ Plus Ureteral Stent 6F x 26cm braided retrieval line 
M0061755630 
Percuflex™ Plus Ureteral Stent 6F x 28cm braided retrieval line 
M0061755640 
Percuflex™ Plus Ureteral Stent 6F x 30cm braided retrieval line 
M0061755650 
Percuflex™ Plus Ureteral Stent 7F x 22cm braided retrieval line 
M0061755710 
Percuflex™ Plus Ureteral Stent 7F x 24cm braided retrieval line 
M0061755720 
Percuflex™ Plus Ureteral Stent 7F x 26cm braided retrieval line 
M0061755730 
Percuflex™ Plus Ureteral Stent 7F x 28cm braided retrieval line 
M0061755740 
Percuflex™ Plus Ureteral Stent 8F x 22cm braided retrieval line 
M0061755810 
Percuflex™ Plus Ureteral Stent 8F x 24cm braided retrieval line 
M0061755820 
Percuflex™ Plus Ureteral Stent 8F x 26cm braided retrieval line 
M0061755830 
Percuflex™ Plus Ureteral Stent 8F x 28cm braided retrieval line 
M0061755840 
Polaris Ureteral Stent 
Polaris™ Ultra Ureteral Stent 5F x 10cm 
M0061921110 
Polaris™ Ultra Ureteral Stent 5F x 12cm 
M0061921120 
Polaris™ Ultra Ureteral Stent 5F x 14cm 
M0061921130 
Polaris™ Ultra Ureteral Stent 5F x 16cm 
M0061921140 
Polaris™ Ultra Ureteral Stent 5F x 18cm 
M0061921150 
Polaris™ Ultra Ureteral Stent 5F x 20cm 
M0061921200 
Polaris™ Ultra Ureteral Stent 5F x 22cm 
M0061921210 
Polaris™ Ultra Ureteral Stent 5F x 24cm 
M0061921220 
Polaris™ Ultra Ureteral Stent 5F x 26cm 
M0061921230 
Polaris™ Ultra Ureteral Stent 5F x 28cm 
M0061921240 
Polaris™ Ultra Ureteral Stent 5F x 30cm 
M0061921250 

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Product Description 
UPN/Product Code 
Polaris™ Ultra Ureteral Stent 6F x 20cm 
M0061921300 
Polaris™ Ultra Ureteral Stent 6F x 22cm 
M0061921310 
Polaris™ Ultra Ureteral Stent 6F x 24cm 
M0061921320 
Polaris™ Ultra Ureteral Stent 6F x 26cm 
M0061921330 
Polaris™ Ultra Ureteral Stent 6F x 28cm 
M0061921340 
Polaris™ Ultra Ureteral Stent 6F x 30cm 
M0061921350 
Polaris™ Ultra Ureteral Stent 7F x 20cm 
M0061921400 
Polaris™ Ultra Ureteral Stent 7F x 22cm 
M0061921410 
Polaris™ Ultra Ureteral Stent 7F x 24cm 
M0061921420 
Polaris™ Ultra Ureteral Stent 7F x 26cm 
M0061921430 
Polaris™ Ultra Ureteral Stent 7F x 28cm 
M0061921440 
Polaris™ Ultra Ureteral Stent 7F x 30cm 
M0061921450 
Polaris™ Ultra Ureteral Stent 8F x 20cm 
M0061921500 
Polaris™ Ultra Ureteral Stent 8F x 22cm 
M0061921510 
Polaris™ Ultra Ureteral Stent 8F x 24cm 
M0061921520 
Polaris™ Ultra Ureteral Stent 8F x 26cm 
M0061921530 
Polaris™ Ultra Ureteral Stent 8F x 28cm 
M0061921540 
Polaris™ Ultra Ureteral Stent 8F x 30cm 
M0061921550 
Tria Firm Ureteral Stent 
Tria™ Firm Ureteral Stent 4.8F x 10cm 
M0061902050 
Tria™ Firm Ureteral Stent 4.8F x 12cm 
M0061902060 
Tria™ Firm Ureteral Stent 4.8F x 14cm 
M0061902070 
Tria™ Firm Ureteral Stent 4.8F x 16cm 
M0061902080 
Tria™ Firm Ureteral Stent 4.8F x 18cm 
M0061902090 
Tria™ Firm Ureteral Stent 4.8F x 20cm 
M0061902100 
Tria™ Firm Ureteral Stent 4.8F x 22cm 
M0061902110 
Tria™ Firm Ureteral Stent 4.8F x 24cm 
M0061902120 
Tria™ Firm Ureteral Stent 4.8F x 26cm 
M0061902130 

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Product Description 
UPN/Product Code 
Tria™ Firm Ureteral Stent 4.8F x 28cm 
M0061902140 
Tria™ Firm Ureteral Stent 4.8F x 30cm 
M0061902150 
Tria™ Firm Ureteral Stent 6F x 20cm 
M0061902200 
Tria™ Firm Ureteral Stent 6F x 22cm 
M0061902210 
Tria™ Firm Ureteral Stent 6F x 24cm 
M0061902220 
Tria™ Firm Ureteral Stent 6F x 26cm 
M0061902230 
Tria™ Firm Ureteral Stent 6F x 28cm 
M0061902240 
Tria™ Firm Ureteral Stent 6F x 30cm 
M0061902250 
Tria™ Firm Ureteral Stent 7F x 20cm 
M0061902300 
Tria™ Firm Ureteral Stent 7F x 22cm 
M0061902310 
Tria™ Firm Ureteral Stent 7F x 24cm 
M0061902320 
Tria™ Firm Ureteral Stent 7F x 26cm 
M0061902330 
Tria™ Firm Ureteral Stent 7F x 28cm 
M0061902340 
Tria™ Firm Ureteral Stent 7F x 30cm 
M0061902350 
Tria™ Firm Ureteral Stent 8F x 20cm 
M0061902400 
Tria™ Firm Ureteral Stent 8F x 22cm 
M0061902410 
Tria™ Firm Ureteral Stent 8F x 24cm 
M0061902420 
Tria™ Firm Ureteral Stent 8F x 26cm 
M0061902430 
Tria™ Firm Ureteral Stent 8F x 28cm 
M0061902440 
Tria™ Firm Ureteral Stent 8F x 30cm 
M0061902450 
Tria™ Firm Ureteral Stent 4.8F x 10cm w/o Sideholes 
M0061902550 
Tria™ Firm Ureteral Stent 4.8F x 12cm w/o Sideholes 
M0061902560 
Tria™ Firm Ureteral Stent 4.8F x 14cm w/o Sideholes 
M0061902570 
Tria™ Firm Ureteral Stent 4.8F x 16cm w/o Sideholes 
M0061902580 
Tria™ Firm Ureteral Stent 4.8F x 18cm w/o Sideholes 
M0061902590 
Tria™ Firm Ureteral Stent 4.8F x 20cm w/o Sideholes 
M0061902600 
Tria™ Firm Ureteral Stent 4.8F x 22cm w/o Sideholes 
M0061902610 
Tria™ Firm Ureteral Stent 4.8F x 24cm w/o Sideholes 
M0061902620 

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Product Description 
UPN/Product Code 
Tria™ Firm Ureteral Stent 4.8F x 26cm w/o Sideholes 
M0061902630 
Tria™ Firm Ureteral Stent 4.8F x 28cm w/o Sideholes 
M0061902640 
Tria™ Firm Ureteral Stent 4.8F x 30cm w/o Sideholes 
M0061902650 
Tria™ Firm Ureteral Stent 6F x 20cm w/o Sideholes 
M0061902700 
Tria™ Firm Ureteral Stent 6F x 22cm w/o Sideholes 
M0061902710 
Tria™ Firm Ureteral Stent 6F x 24cm w/o Sideholes 
M0061902720 
Tria™ Firm Ureteral Stent 6F x 26cm w/o Sideholes 
M0061902730 
Tria™ Firm Ureteral Stent 6F x 28cm w/o Sideholes 
M0061902740 
Tria™ Firm Ureteral Stent 6F x 30cm w/o Sideholes 
M0061902750 
Tria™ Firm Ureteral Stent 7F x 20cm w/o Sideholes 
M0061902800 
Tria™ Firm Ureteral Stent 7F x 22cm w/o Sideholes 
M0061902810 
Tria™ Firm Ureteral Stent 7F x 24cm w/o Sideholes 
M0061902820 
Tria™ Firm Ureteral Stent 7F x 26cm w/o Sideholes 
M0061902830 
Tria™ Firm Ureteral Stent 7F x 28cm w/o Sideholes 
M0061902840 
Tria™ Firm Ureteral Stent 7F x 30cm w/o Sideholes 
M0061902850 
Tria™ Firm Ureteral Stent 8F x 20cm w/o Sideholes 
M0061902900 
Tria™ Firm Ureteral Stent 8F x 22cm w/o Sideholes 
M0061902910 
Tria™ Firm Ureteral Stent 8F x 24cm w/o Sideholes 
M0061902920 
Tria™ Firm Ureteral Stent 8F x 26cm w/o Sideholes 
M0061902930 
Tria™ Firm Ureteral Stent 8F x 28cm w/o Sideholes 
M0061902940 
Tria™ Firm Ureteral Stent 8F x 30cm w/o Sideholes 
M0061902950 
Tria Soft Ureteral Stent 
Tria™ Soft Ureteral Stent 6F x 20cm 
M0061903200 
Tria™ Soft Ureteral Stent 6F x 22cm 
M0061903210 
Tria™ Soft Ureteral Stent 6F x 24cm 
M0061903220 
Tria™ Soft Ureteral Stent 6F x 26cm 
M0061903230 
Tria™ Soft Ureteral Stent 6F x 28cm 
M0061903240 
Tria™ Soft Ureteral Stent 6F x 30cm 
M0061903250 

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Product Description 
UPN/Product Code 
Tria™ Soft Ureteral Stent 7F x 20cm 
M0061903300 
Tria™ Soft Ureteral Stent 7F x 22cm 
M0061903310 
Tria™ Soft Ureteral Stent 7F x 24cm 
M0061903320 
Tria™ Soft Ureteral Stent 7F x 26cm 
M0061903330 
Tria™ Soft Ureteral Stent 7F x 28cm 
M0061903340 
Tria™ Soft Ureteral Stent 7F x 30cm 
M0061903350 
Tria™ Soft Ureteral Stent 8F x 20cm 
M0061903400 
Tria™ Soft Ureteral Stent 8F x 22cm 
M0061903410 
Tria™ Soft Ureteral Stent 8F x 24cm 
M0061903420 
Tria™ Soft Ureteral Stent 8F x 26cm 
M0061903430 
Tria™ Soft Ureteral Stent 8F x 28cm 
M0061903440 
Tria™ Soft Ureteral Stent 8F x 30cm 
M0061903450 
Tria™ Soft Ureteral Stent 6F x 20cm w/o Sideholes 
M0061903700 
Tria™ Soft Ureteral Stent 6F x 22cm w/o Sideholes 
M0061903710 
Tria™ Soft Ureteral Stent 6F x 24cm w/o Sideholes 
M0061903720 
Tria™ Soft Ureteral Stent 6F x 26cm w/o Sideholes 
M0061903730 
Tria™ Soft Ureteral Stent 6F x 28cm w/o Sideholes 
M0061903740 
Tria™ Soft Ureteral Stent 6F x 30cm w/o Sideholes 
M0061903750 
Tria™ Soft Ureteral Stent 7F x 20cm w/o Sideholes 
M0061903800 
Tria™ Soft Ureteral Stent 7F x 22cm w/o Sideholes 
M0061903810 
Tria™ Soft Ureteral Stent 7F x 24cm w/o Sideholes 
M0061903820 
Tria™ Soft Ureteral Stent 7F x 26cm w/o Sideholes 
M0061903830 
Tria™ Soft Ureteral Stent 7F x 28cm w/o Sideholes 
M0061903840 
Tria™ Soft Ureteral Stent 7F x 30cm w/o Sideholes 
M0061903850 
Percuflex Urinary Diversion Stent 
Percuflex Urinary Diversion Stent Set, Open Tip 6Fr (2.0mm) x 80cm 
M0061602050 
Percuflex Urinary Diversion Stent Set, Open Tip 7Fr (2.3mm) x 80cm 
M0061602100 
Percuflex Urinary Diversion Stent Set, Open Tip 8Fr (2.7mm) x 80cm 
M0061602150 
Percuflex Urinary Diversion Stent Set, Closed Tip 6Fr (2.0mm) x 80cm 
M0061602250 
Percuflex Urinary Diversion Stent Set, Closed Tip 7Fr (2.3mm) x 80cm 
M0061602300 

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Product Description 
UPN/Product Code 
Percuflex Urinary Diversion Stent Set, Closed Tip 8Fr (2.7mm) x 80cm 
M0061602350 
Polaris Loop Ureteral Stent 
 
Polaris Loop Ureteral Stent, 5 Fr x 10cm 
M0061552110 
Polaris Loop Ureteral Stent, 5 Fr x 12cm 
M0061552120 
Polaris Loop Ureteral Stent, 5 Fr x 14cm 
M0061552130 
Polaris Loop Ureteral Stent, 5 Fr x 16cm 
M0061552140 
Polaris Loop Ureteral Stent, 5 Fr x 18cm 
M0061552150 
Polaris Loop Ureteral Stent, 5 Fr x 20cm 
M0061552200 
Polaris Loop Ureteral Stent, 5 Fr x 22cm 
M0061552210 
Polaris Loop Ureteral Stent, 5 Fr x 24cm 
M0061552220 
Polaris Loop Ureteral Stent, 5 Fr x 26cm 
M0061552230 
Polaris Loop Ureteral Stent, 5 Fr x 28cm 
M0061552240 
Polaris Loop Ureteral Stent, 5 Fr x 30cm 
M0061552250 
Polaris Loop Ureteral Stent, 6 Fr x 20cm 
M0061552300 
Polaris Loop Ureteral Stent, 6 Fr x 22cm 
M0061552310 
Polaris Loop Ureteral Stent, 6 Fr x 24cm 
M0061552320 
Polaris Loop Ureteral Stent, 6 Fr x 26cm 
M0061552330 
Polaris Loop Ureteral Stent, 6 Fr x 28cm 
M0061552340 
Polaris Loop Ureteral Stent, 6 Fr x 30cm 
M0061552350 
Polaris Loop Ureteral Stent, 7 Fr x 20cm 
M0061552400 
Polaris Loop Ureteral Stent, 7 Fr x 22cm 
M0061552410 
Polaris Loop Ureteral Stent, 7 Fr x 24cm 
M0061552420 
Polaris Loop Ureteral Stent, 7 Fr x 26cm 
M0061552430 
Polaris Loop Ureteral Stent, 7 Fr x 28cm 
M0061552440 
Polaris Loop Ureteral Stent, 7 Fr x 30cm 
M0061552450 
Polaris Loop Ureteral Stent, 8 Fr x 20cm 
M0061552500 
Polaris Loop Ureteral Stent, 8 Fr x 22cm 
M0061552510 
Polaris Loop Ureteral Stent, 8 Fr x 24cm 
M0061552520 
Polaris Loop Ureteral Stent, 8 Fr x 26cm 
M0061552530 
Polaris Loop Ureteral Stent, 8 Fr x 28cm 
M0061552540 
Polaris Loop Ureteral Stent, 8 Fr x 30cm 
M0061552550 
Contour™ SureDrive™ Steerable Ureteral Stent (with steerable positioner) 
Contour™ SureDrive™ Steerable Ureteral Stent Set 6Fx20cm 
M0061458590 
Contour™ SureDrive™ Steerable Ureteral Stent Set 6Fx22cm 
M0061458600 
Contour™ SureDrive™ Steerable Ureteral Stent Set 6Fx24cm 
M0061458610 
Contour™ SureDrive™ Steerable Ureteral Stent Set 6Fx26cm 
M0061458620 
Contour™ SureDrive™ Steerable Ureteral Stent Set 6Fx28cm 
M0061458630 
Contour™ SureDrive™ Steerable Ureteral Stent Set 7Fx20cm 
M0061458640 

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Product Description 
UPN/Product Code 
Contour™ SureDrive™ Steerable Stent Set 7Fx22cm 
M0061458650 
Contour™ SureDrive™ Steerable Stent Set 7Fx24cm 
M0061458660 
Contour™ SureDrive™ Steerable Stent Set 7Fx26cm 
M0061458670 
Contour™ SureDrive™ Steerable Stent Set 7Fx28cm 
M0061458680 
Contour™ SureDrive™ Steerable  Stent Set 8Fx22cm 
M0061458690 
Contour™ SureDrive™ Steerable Stent Set 8Fx24cm 
M0061458700 
Contour™ SureDrive™ Steerable Stent Set 8Fx26cm 
M0061458710 
Contour™ SureDrive™ Steerable Stent Set 8Fx28cm 
M0061458720 
Contour™ VL SureDrive™ Steerable Ureteral Stent (with steerable positioner) 
Contour VL™ SureDrive™ Steerable Ureteral Stent Set 4.8Fx22cm-30cm 
M0061458730 
Contour VL™ SureDrive™ Steerable Ureteral Stent Set 6Fx22cm-30cm 
M0061458740 
Contour VL™ SureDrive™ Steerable Ureteral Stent Set 7Fx22cm-30cm 
M0061458750 
Contour™ Injection Stent Sets and Contour VL™ Injection Stent Sets 
Contour™ Injection Stent Set 4.8Fx24cm 
M0061856070 
Contour™ Injection Stent Set 4.8Fx26cm 
M0061856080 
Contour™ Injection Stent Set 4.8Fx28cm 
M0061856090 
Contour™ Injection Stent Set 6Fx22cm 
M0061856120 
Contour™ Injection Stent Set 6Fx24cm 
M0061856130 
Contour™ Injection Stent Set 6Fx26cm 
M0061856140 
Contour™ Injection Stent Set 6Fx28cm 
M0061856150 
Contour™ Injection Stent Set 6Fx30cm 
M0061856160 
Contour™ Injection Stent Set 7Fx20cm 
M0061856170 
Contour™ Injection Stent Set 7Fx22cm 
M0061856180 
Contour™ Injection Stent Set 7Fx24cm 
M0061856190 
Contour™ Injection Stent Set 7Fx26cm 
M0061856200 
Contour™ Injection Stent Set 7Fx28cm 
M0061856210 
Contour™ Injection Stent Set 7Fx30cm 
M0061856220 
Contour VL™ Injection Stent Set - Variable Length Injection Stent Set 
4.8Fx22cm-30cm 
*M0061856290 
Contour VL™ Injection Stent Set - Variable Length Injection Stent Set 
6Fx22cm-30cm 
*M0061856300 
Contour VL™ Injection Stent Set - Variable Length Injection Stent Set 
7Fx22-30cm 
*M0061856310 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent (with steerable positioner) 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 4.8Fx20cm 
M0061457410 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 4.8Fx22cm 
M0061457420 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 4.8Fx24cm 
M0061457430 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 4.8Fx26cm 
M0061457440 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 4.8Fx28cm 
M0061457450 

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Product Description 
UPN/Product Code 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 6Fx20cm 
M0061457460 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 6Fx22cm 
M0061457470 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 6Fx24cm 
M0061457480 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 6Fx26cm 
M0061457490 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 6Fx28cm 
M0061457500 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 7Fx20cm 
M0061458500 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 7Fx22cm 
M0061458510 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 7Fx24cm 
M0061458520 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 7Fx26cm 
M0061458530 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 7Fx28cm 
M0061458540 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 8Fx22cm 
M0061458550 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 8Fx24cm 
M0061458560 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 8Fx26cm 
M0061458570 
Percuflex™ Plus SureDrive™ Steerable Ureteral Stent Set 8Fx28cm 
M0061458580 
 
27.2. Appendix 2 Clavien-Dindo Classification 
Grades 
Definition 
Grade I 
Any deviation from the normal postoperative course without the need 
for pharmacological treatment or surgical, endoscopic and radiological 
interventions 
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, 
analgetics, diuretics and electrolytes and physiotherapy. This grade also 
includes wound infections opened at the bedside. 
Grade II 
Requiring pharmacological treatment with drugs other than such 
allowed for grade I complications. 
Blood transfusions and total parenteral nutrition are also included. 
Grade III 
Requiring surgical, endoscopic or radiological intervention 
       - IIIa 
Intervention not under general anesthesia 
       - IIIb 
Intervention under general anesthesia 
Grade IV 
Life-threatening complication (including CNS complications)* 
requiring IC/ICU-management 
       - IVa 
single organ dysfunction (including dialysis) 
       - IVb 
Multiorgan dysfunction 
Grade V 
Death of a patient 
Suffix “d” 
d for disability 
*brain hemorrhage, ischemic stroke, subarrachnoidalbleeding,but excluding transient ischemic attacks (TIA);IC: 
Intermediate care; ICU: Intensive care unit.