Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections
Conditions: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Sponsor: Medtronic Cardiovascular

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 51 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Secondary endovascular procedures for primary device failures (including Type I/III 
endoleaks, aneurysm expansion, aneurysm/aortic rupture, and BSG occlusion) 
• Rupture 
• Endoleaks 
• Maximum aneurysm diameter change from baseline* 
• Exclusion of aneurysm  
• Exclusion of penetrating aortic ulcer (PAU)  
• Stent graft patency 
• Stent graft integrity 
• Conversion to surgery 
• Surgical revascularization of the LSA 
• Paraparesis 
• Adverse events including serious adverse events and device, procedure, and/or 
disease-related Adverse Events  
• For CTBD, these additional observations will be evaluated:  
o Coverage of primary entry tear (exclusion of false lumen) 
o Extension of dissection (proximally or distally) with or without complications 
o Continuing or new false lumen (FL) perfusion 
▪ Primary intimal tear false lumen perfusion (PIT FLP) 
▪ Proximal aorta false lumen perfusion (PA FLP) 
▪ Distal aorta false lumen perfusion (DA FLP) 
▪ Proximal branch false lumen perfusion (PB FLP) 
▪ Distal branch false lumen perfusion (DB FLP) 
o Aortic remodeling post-procedure as measured by: 
▪ Change from baseline* in the maximum true lumen (TL) diameter 
over the length of the stent graft  
▪ Change from baseline* in the maximum false lumen (FL) diameter 
over the length of the stent graft  
▪ Change from baseline* in the maximum total descending thoracic 
aortic diameter 
▪ FL thrombosis over the length of the stent graft 
* The discharge computerized tomography angiogram (CTA) will be used as baseline to 
assess aortic changes. If a discharge CTA is not performed, then the one month follow-up 
CTA will be used for baseline purposes.   
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 52 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
7.1.4 Periprocedural and Discharge Clinical Utility Measures 
The following periprocedural through discharge clinical utility measures will be summarized 
using descriptive statistics.  
1. Mean duration (min) of procedure. 
2. Mean time (min) to implant the LSA Branch device. 
3. Proportion of subjects who underwent general anesthesia. 
4. Mean volume (cc) of estimated blood loss. 
5. Proportion of subjects requiring blood transfusions. 
6. Mean time (hours) in intensive care unit. 
7. Mean time (days) of overall hospital stay (from hospital admission to discharge). 
 
7.2 SAMPLE SIZE CALCULATIONS 
There is no sample size calculation since this is not a hypothesis driven study. 
 
7.3 ANALYSIS OF OBSERVATIONS 
7.3.1 Data Analysis Set 
An analysis set will be constructed from the Valiant Mona LSA Stent Graft subjects. All 
safety and effectiveness analyses will be performed on all enrolled subjects, according to 
the intention-to-treat (ITT) principle. The subject will be considered enrolled after arterial 
access is achieved and the Valiant Mona LSA Thoracic Stent Graft System has been 
introduced into the vasculature. 
 
7.3.2 Analysis of the Primary Safety Observation 
Descriptive statistics (frequency and percentage) will be calculated for the primary safety 
observation and its component events. 
 
7.3.3 Analysis of the Primary Effectiveness Observation 
Descriptive statistics (frequency and percentage) will be calculated for the primary 
effectiveness observation of Treatment Success within 1-month. 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 53 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
7.3.4 Analysis of the Additional Observations 
Descriptive statistics for categorical variables (frequency and percentage) will be 
calculated for all of the secondary observations.  
 
7.3.5 Analysis of the Periprocedural through Discharge Clinical Utility Measures 
Descriptive statistics will be calculated - Categorical variables, including binary variables, 
will be reported by giving the number and percentage of subjects in each category; 
Continuous variables will be reported by presenting the mean, Standard Deviation (S.D.), 
median, minimum, and maximum of each variable. 
 
7.3.6 Analysis of Baseline Variables 
All clinically relevant baseline variables will be tabulated. Descriptive statistics will be 
calculated. Categorical variables, including binary variables, will be reported by giving the 
number and percentage of patients in each category. Continuous variables will be reported 
by presenting the mean, S.D., median, minimum, and maximum of each variable. For all 
baseline variables, only patients with evaluable assessments will be included. 
 
7.3.7 Subset Analyses 
Subset analyses of the primary safety and effectiveness observations will be created for 
each indication -  aneurysms, penetrating ulcers, and chronic Type B dissections. 
 
Descriptive statistics will be used for each subset to analyze the primary observations, 
additional observations, and periprocedural and discharge clinical utility measures as 
outlined in Sections 7.1.1, 7.1.2, 7.1.3, and 7.1.4 above.    
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 54 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
7.3.8 Time Window Conventions Used in Analysis of Observations 
Throughout this study, all attempts will be made to collect complete and compliant data. 
Thus, the majority of data are expected to be within the protocol-specified timeframes for 
follow-up visits. However, in practice, it may not be possible to achieve this completely. 
For example, an unscheduled visit may take place and then the patient may miss the next 
follow-up or withdraw.  
For these exceptions, and to take into account all available data, the following rules and 
time windows will be applied in the statistical analyses for imaging observations (Table 
7-1).  
Table 7-1: Windows and Analysis of Noncompliance or Missing Data 
Study Visit 
Target Day 
Scheduled Follow-
Up Window 
Analysis Window 
for Imaging Assessments 
Implant 
0 
Day 0 
Day 0 
1 Month 
30 
15-45 Days 
1-122 Days 
6 Months 
183 
153-239 Days 
123-270 Days 
12 Months 
365 
335-421 Days 
271-480 Days 
24 Months 
730 
674-842 Days 
481-913 Days 
36 Months 
1095 
1039-1207 Days 
914-1278 Days 
48 Months 
1460 
1404-1572 Days 
1279-1644 Days 
60 Months 
1825 
1769-1937 Days 
1645-2008 Days 
 
If follow-up data are not available for a specific visit, subsequent follow-up data may be 
used, e.g., when there is evidence of stent graft patency, endoleak, or freedom from 
migration at 12-months post index procedure. The larger time window around the 12-

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 55 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
month visit takes this into account. If there are 2 or more assessments in the same time 
window, then the assessment closest to the target day will be used in the analysis. 
For an adverse event or death, date of onset will be defined as the time when the event 
occurred. In cases where the date of onset is incomplete, the 15th day of the known month 
or July 1st of the known year will be used.  
Furthermore, adverse events or death may be observed at any time during the study, so no 
time windows will be applied. An event that occurs “within 1 month” is an event that takes 
place between Days 0 to Day 30 inclusive. The same applies to events for the 12-month 
window, i.e., Day 0 – Day 365 inclusive. 
 
7.3.9 Patient Withdrawal and Missing Data 
In general, all analyses will be performed using the ITT analysis set, which constitutes all 
available (or observed) cases. Imputation of missing data will not be performed. For 
example, to determine the rate of freedom from MAEs, all subjects with MAEs reported or 
no MAEs observed during the defined time period will be counted in the analysis.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 56 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
8. CLINICAL STUDY PREPARATION PROCEDURES 
As the Sponsor of this clinical study, Medtronic Vascular has the overall responsibility for 
the conduct of the study, including assurance that the study will be conducted according 
to the Investigational Plan and the US Food and Drug Administration (FDA) regulations. 
During this study, Medtronic Vascular will have certain direct responsibilities and may 
delegate other responsibilities to, for example, a CRO. Medtronic Vascular and/or its 
designees will conform to the US Code of Federal Regulations (CFR) including but not 
limited to: Investigational Device Exemptions (21 CFR 812), Electronic Records/Electronic 
Signatures (21 CFR 11), Protection of Human Subjects (21 CFR Part 50), Financial 
Disclosure by Clinical Investigators (21 CFR Part 54), and Institutional Review Boards (21 
CFR 56). 
 
8.1 SELECTION OF CLINICAL INVESTIGATORS 
Investigators who are qualified by training and experience will be selected to participate in 
this study. All investigators will sign the appropriate study-related agreements 
(Investigator/Sub-Investigator Agreement and Clinical Research Agreement) before they 
are added to the clinical study. 
 
8.2 INSTITUTIONAL REVIEW BOARD REQUIREMENTS 
Investigators are required to submit all required study documents to the Institutional 
Review Board (IRB) with oversight responsibility for the study center. The investigator 
must notify Medtronic Vascular when IRB approval is granted and provide a copy of the 
approval letter and approved informed consent form. 
 
8.3 INFORMED CONSENT 
All subjects must provide written informed consent in accordance with 21 CFR Part 50, 
Part 812 and local law. Informed Consent must be obtained from all study subjects prior to 
initiation of any study required activity that is not standard of care/routine medical care 
administered by the investigator for this patient population. The informed consent form 
must be signed by the subject or the subject's legally authorized representative. A sample 
Informed Consent is included in Appendix E. Each Investigational Site must provide 
Medtronic with a copy of the Informed Consent approved for use by the site’s Institutional 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 57 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Review Board (IRB). The original signed Informed Consent should be retained in the study 
subject's study records. 
It is recommended that the informed consent document have an IRB approval stamp and 
be version controlled. The informed consent process should be documented in the 
patient’s medical record. The original informed consent document should be filed at the 
investigational site and a copy of the signed informed consent should be given to the 
subject.  
 
8.4 STUDY TRAINING 
Prior to the start of the study, the investigator and study staff at each site will undergo 
training to provide in-depth information about the use of the device, the clinical 
investigational plan, and study requirements. Medtronic Vascular personnel (or designees) 
will conduct the training. Training of study personnel will be documented on the 
appropriate training record form and maintained at the site and in the Medtronic Vascular 
study files.  
Physician proctoring will be provided to the Investigators as directed by Medtronic 
Vascular. Medtronic personnel may be present for the investigational implants at sites. 
 
8.5 REQUIRED INVESTIGATIONAL EQUIPMENT 
The following devices packaged will be provided for this clinical investigation. Devices will 
be labeled with the required investigational caution language. The Valiant Mona LSA Stent 
Graft IFU is provided in Appendix A and labeling is found in Appendix F.  
The Valiant Mona LSA Thoracic Stent Graft Systems are composed of the following 
components. 
• Main Stent Graft 
• Branch Stent Graft 
• Main Delivery System 
• Branch Delivery System 
Each stent graft component (e.g., main stent graft or branch stent graft) is individually 
contained within a delivery system. The delivery systems are sterilized using E-beam and 
are supplied sterile for single use only. The system should be stored at room temperature 
in a secure, dark, dry place. Ancillary required and recommended equipment associated 
with implantation of the Valiant Mona LSA Thoracic Stent Graft System are listed in the 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 58 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Valiant Mona LSA Thoracic Stent Graft System Instructions for Use—Section 9: Clinician 
Use Information (Appendix A and as packaged with the investigational device). 
After proper measurements and a therapeutic plan are established for a subject, the 
appropriate components of the Valiant Mona LSA Thoracic Stent Graft System will be 
shipped to the site (refer to the IFU in Appendix A and the packaged device for sizes 
available). Only the investigator and the clinical study staff should have access to the 
investigational system components. 
 
8.6  SITE ACTIVATION AND SUPPLY OF STUDY MATERIALS 
Investigators will receive written approval to commence study enrollment from Medtronic 
Vascular after all required regulatory documents are received and training has occurred. 
The Investigator is responsible for supervising the use of all investigational devices. 
Medtronic Vascular will control the supply of study devices, case report form materials, 
return shipment containers for explanted devices, and other items required to conduct the 
clinical study.  
 
8.7 PROTOCOL AMENDMENTS 
The investigator can propose any appropriate modification(s) of the clinical investigation 
plan or investigational device or investigational device use. Medtronic will review this 
proposal and decide whether the modification(s) will be implemented.  
Medtronic will submit any significant amendment to the clinical investigation plan, 
including a justification for this amendment, to the appropriate regulatory authorities and 
to the investigators to obtain approval from their IRB/EC. The investigator will only 
implement the amendment after approval of the IRB/EC, regulatory authority and sponsor. 
Administrative amendments to the clinical investigation plan will be submitted to the 
IRB/EC for notification. Furthermore, investigators shall sign any approved amendment of 
the clinical investigation plan, if required per local regulation.  
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 59 of 200 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9.  CLINICAL STUDY PROCEDURES 
Clinical data will be collected preoperatively to establish eligibility, at baseline, during 
implantation of the Valiant Mona LSA Stent Graft, throughout the hospital stay, and 
postoperatively. Each subject will continue to be followed after the 30-day, 6-month, and 
12-month evaluation on an annual basis to collect a total of 5 years’ experience. When all 
enrolled subjects have been followed for 5 years post index procedure or have previously 
exited from the study, the study will be closed and the final report generated.  
Study data will be collected using electronic case report forms (eCRFs). eCRFs should be 
electronically reviewed and approved by the clinical investigators. Medtronic Vascular 
monitors (or designees) will review all case report forms.  
The data collection schedule is summarized in Table 9-1.  
 
 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
Page 60 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
  056-F275, v3.0 Clinical Investigation Plan Template 
 
Table 9-1: Overview of the Study Procedures and Data Collection Requirements 
Data 
Screening/ 
Baseline 
Procedure 
Hospital 
Discharge 
1-Month FU 
±15 days 
6-Month FU 
-30 /+56 days 
12-Month FU 
-30 days/ +56 days 
2 - 5 Year FU 
-8 /+16 weeks 
GENERAL 
 
 
 
 
 
 
 
Informed Consent 
✓ 
 
 
 
 
 
 
Physical Examination (Left arm assessment; pulses, BP in both arms) 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
Medical History 
✓ 
 
 
 
 
 
 
Current Health Status and Risk Factors 
✓ 
 
 
 
 
 
 
Pregnancy Test (for female of child-bearing potential) 
✓ 
 
 
 
 
 
 
Laboratory Tests: CBC, creatinine, and INR (if subject taking Coumadin)  
✓77 
 
✓78 
✓78 
✓78 
✓78 
✓78 
Device and Procedure Information 
 
✓ 
 
 
 
 
 
Neurological Evaluation79 
✓ 
 
 
 
 
 
 
Hospital Discharge Information 
 
 
✓ 
 
 
 
 
Pre-Implant Adjunctive Procedures 
 
✓ 
 
 
 
 
 
Adverse Event Assessment 
 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
IMAGING 
 
 
 
 
 
 
 
3D CTA with contrast (aorta and thoracic branch vessels)  
✓ 
 
✓ 
✓ 
✓ 
✓ 
✓ 
3D CTA of head/neck/abdomen/pelvis 
✓ 
 
 
 
 
 
 
DUS of the LSA/Carotid vessels 
✓ 
 
 
 
 
 
 
DUS of the LSA/thoracic branch vessels 
 
 
✓ 
✓ 
✓ 
✓ 
✓ 
Angiogram of Thoracic aorta  
 
✓ 
 
 
 
 
 
Chest X-Ray  
  
 
✓ 
✓ 
✓ 
✓ 
✓ 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
Page 61 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
  056-F275, v3.0 Clinical Investigation Plan Template 
 
Table 9-1: Overview of the Study Procedures and Data Collection Requirements 
Data 
Screening/ 
Baseline 
Procedure 
Hospital 
Discharge 
1-Month FU 
±15 days 
6-Month FU 
-30 /+56 days 
12-Month FU 
-30 days/ +56 days 
2 - 5 Year FU 
-8 /+16 weeks 
ADDITIONAL PROCEDURES REQUIRED IF A POST-OPERATIVE NEUROLOGICAL 
CHANGE OCCURS 
 
 
 
 
 
 
 
Neurological Evaluation80 
 
 
✓ 
✓ 
✓ 
✓ 
✓ 
Diffusion-weighted MRI of head/neck 
 
 
✓ 
✓ 
✓ 
✓ 
✓ 
                                                 
77 CBC, serum creatinine, and INR (if subject is taking Coumadin pre-operatively) are required at baseline only.  
78 Serum creatinine is required post-operatively at each visit, from discharge through 5 years. 
79 Refer to section 9.2 for neurological evaluation testing requirements at baseline. 
80 Refer to section 9.4 for neurological evaluation testing requirements for discharge, 1 month, 6 months, 12 months, and annually through 5 years. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 62 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9.1 ELIGIBILITY CRITERIA 
The study population will include those patients diagnosed with an aneurysmal thoracic 
aorta, penetrating ulcer, or chronic type B dissection who are candidates for 
revascularization of the left subclavian artery (LSA) and who meet the inclusion and 
exclusion criteria. Data will be recorded on the Inclusion and Exclusion Criteria Form. 
Following review of the preliminary safety data of the first 18 enrolled patients, 5 additional 
subjects with TAA or PAU will be enrolled to further evaluate the device’s safety. 
The safety data for these 5 subjects will be reviewed by the investigator(s) in coordination 
with MDT and the DSMB to determine whether to start enrollment of the CTBD arm. 
 
9.1.1 Inclusion Criteria for Thoracic Aortic Aneurysms and Penetrating Ulcers 
• Subject is at least 18 years of age.  
• Subject understands and has signed an Informed Consent approved by the Sponsor 
and by the IRB for this study. 
• Subject must be considered a candidate for revascularization of the Left Subclavian 
Artery). Subject must be able to tolerate a surgical revascularization of the LSA. 
• Subject has a TAA/PAU which will require coverage of the LSA and is: 
o a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter 
of the non-aneurysmal thoracic aorta;  
AND/OR 
o a saccular aneurysm or penetrating atherosclerotic ulcer (ulcer defined as ≥ 
10 mm in depth and 20 mm in diameter, or symptomatic) 
• Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm 
from the distal end of the LCC ostium to the beginning of the disease, including at 
least 10 mm between the LSA and the LCC. 
• Subject has a non -diseased aortic proximal neck length of >0mm distal to the LSA 
• Subject has a non-diseased aortic diameter between 25 mm and 42 mm  
• Subject has a non-diseased LSA with a diameter between 8 mm and 13 mm. 
• Subject has sufficient landing zone within the LSA to accommodate the BSG 
without occlusion of any significant vessels 
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, 
tortuosity) that is compatible with vascular access techniques, the device, or 
accessories.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 63 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
▪  Introducer sheath is required for all procedures. 
▪ An iliac conduit is required for access if the above requirements are 
not met.  
 
9.1.2 Exclusion Criteria for Thoracic Aortic Aneurysms and Penetrating Ulcers 
• Subjects will be excluded if they have conditions requiring prospective 
revascularization of the LSA including: 
o Dominant left vertebral artery requiring revascularization 
o Prior coronary artery bypass graft utilizing the left mammary artery requiring 
revascularization 
o Incomplete circle of Willis or other neurological vasculature requiring 
revascularization 
• Subject has an aneurysmal, tortuous, or atherosclerotic LSA. 
• Subject has an acute dissection of the descending thoracic aorta. 
• Subject has an intramural hematoma of the descending thoracic aorta. 
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended 
fixation sites.  
• Subject has circumferential calcification in the external iliac artery or in the common 
iliac artery with an intraluminal diameter (ID) less than 10mm at any point proximal 
to or at the access vessel site unless a surgical adjunctive procedure is planned.  
• Subject requiring an aortic conduit or direct aortic access. 
• Subject has an aortic atheroma classified as grade IV or grade V. 
• Subject has had previous endovascular repair of the ascending and/or descending 
thoracic aorta <30 days of implantation of investigational device or previous repair 
was a non-Medtronic device. 
• Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require 
intentional coverage of the left common carotid artery with the stent graft fabric. 
• Subject has significant and/or circumferential aortic mural thrombus at either the 
proximal or distal attachment sites that would compromise fixation and seal of the 
device. 
• Subject is a pregnant female. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 64 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Subject has a known allergy or intolerance to the device components. 
• Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 
2.0 mg/dL or is on dialysis. 
• Subject has a body habitus which prevents adequate visualization of the aorta. 
• Subject has coronary artery disease with unstable angina and who has not received 
treatment.  
• Subject has a connective tissue disease (e.g. Marfan’s syndrome, medial 
degeneration). 
• Subject has active systemic infection and/or a mycotic aneurysm. 
• Subject is currently participating in an investigational drug or device clinical trial that 
would interfere with the observations of this study. 
• Subject has other medical, social, or psychological problems that, in the opinion of 
the investigator, will interfere with treatment and follow-up procedures. 
• Subject has a life expectancy of less than 1 year. 
• Subject requires treatment of an infrarenal aneurysm at the time of the 
implantation. 
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic 
aneurysm <30 days of implantation of investigational device. 
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood 
transfusion. 
• Subject has had a cerebral vascular accident (CVA) within 3 months prior to the 
procedure. 
• Subject has had a myocardial infarction (MI) within 3 months prior to the procedure. 
• Subject has a known hypersensitivity or contraindication to anticoagulants or 
contrast media, which is not amenable to pre-treatment. 
9.1.3 Inclusion Criteria for Chronic Type B Dissections 
• Subject is at least 18 years of age.  
• Subject understands and has signed an Informed Consent approved by the Sponsor 
and by the IRB for this study. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 65 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Subject must be considered a candidate for revascularization of the Left Subclavian 
Artery (LSA). Subject must be able to tolerate a surgical revascularization of the 
LSA. 
• Subject has a chronic type B dissection which will require coverage of the LSA. A 
chronic type B dissection is defined as > 30 days from symptom onset and is 
complicated with an aortic diameter ≥ 5.5 cm or has progressive aortic enlargement 
(> 5 mm/year). 
• Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm 
from the distal end of the LCC ostium to the beginning of the disease, including at 
least 10 mm between the LSA and the LCC 
• Subject has a non-diseased aortic diameter between 28 mm to 44 mm.  
• Subject has a non-diseased LSA with a diameter between 8 mm and 13 mm. 
• Subject has sufficient landing zone within the LSA to accommodate the BSG 
without occlusion of any significant vessels 
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, 
tortuosity) that is compatible with vascular access techniques, the device, or 
accessories.  
▪ Introducer sheath is required for all procedures. 
▪ An iliac conduit is required for access if these requirements are not 
met.  
 
9.1.4 Exclusion Criteria for Chronic Type B Dissections 
• Subjects will be excluded if they have conditions requiring prospective 
revascularization of the LSA including: 
o Dominant left vertebral artery requiring revascularization 
o Prior coronary artery bypass graft utilizing the left mammary artery requiring 
revascularization 
o Incomplete circle of Willis or other neurological vasculature requiring 
revascularization 
• Subject has an aneurysmal, tortuous, or atherosclerotic LSA. 
• Subject has an acute dissection of the descending thoracic aorta. 
• Subject has an intramural hematoma of the descending thoracic aorta. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 66 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended 
fixation sites. 
• Subject has circumferential calcification in the external iliac artery or in the common 
iliac artery with an intraluminal diameter (ID) less than 10mm at any point proximal 
to or at the access vessel site unless a surgical adjunctive procedure is planned.  
• Subject requiring an aortic conduit or direct aortic access.  
• Subject has an aortic atheroma classified as grade IV or grade V. 
• Subject has had previous endovascular repair of the ascending and/or descending 
thoracic aorta <30 days of implantation of investigational device or previous repair 
was a non-Medtronic device. 
• Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require 
intentional coverage of the left common carotid artery with the stent graft fabric. 
• Subject has significant and/or circumferential aortic mural thrombus at either the 
proximal or distal attachment sites that would compromise fixation and seal of the 
device. 
• Subject is a pregnant female. 
• Subject has a known allergy or intolerance to the device components. 
• Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 
2.0 mg/dL or is on dialysis. 
• Subject has a body habitus which prevents adequate visualization of the aorta. 
• Subject has coronary artery disease with unstable angina and who has not received 
treatment.  
• Subject has a connective tissue disease (e.g. Marfan’s syndrome, medial 
degeneration). 
• Subject has active systemic infection and/or a mycotic aneurysm. 
• Subject is currently participating in an investigational drug or device clinical trial that 
would interfere with the observations of this study. 
• Subject has other medical, social, or psychological problems that, in the opinion of 
the investigator, will interfere with treatment and follow-up procedures. 
• Subject has a life expectancy of less than 1 year. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 67 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Subject requires treatment of an infrarenal aneurysm at the time of the 
implantation. 
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic 
aneurysm <30 days of implantation of investigational device. 
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood 
transfusion. 
• Subject has had a cerebral vascular accident (CVA) within 3 months prior to the 
procedure. 
• Subject has had a myocardial infarction (MI) within 3 months prior to the procedure. 
• Subject has a known hypersensitivity or contraindication to anticoagulants or 
contrast media, which is not amenable to pre-treatment. 
9.2 PATIENT SCREENING, ENROLLMENT, AND PRE-IMPLANT PROCEDURES 
Investigators will assess potential patients diagnosed with fusiform/saccular aneurysm of 
the descending thoracic aorta, penetrating ulcer, or chronic type B dissection who are 
candidates for revascularization of the LSA and anatomically appropriate for the device for 
suitability for enrollment. Following review of the preliminary safety data of the first 18 
enrolled patients, 5 additional subjects with TAA or PAU will be enrolled to further evaluate 
the device’s safety. 
The safety data for these 5 subjects will be reviewed by the investigator(s) in coordination 
with MDT and the DSMB to determine whether to start enrollment of the CTBD arm. 
Initially, patient eligibility will be determined by the investigator based on the diagnosis of 
DTA, penetrating ulcer, or chronic type B dissection as evidenced on screening contrast-
enhanced CT/MRA. If the patient appears to meet the eligibility criteria, then the 
investigator will discuss the study with the patient and provide information relating to the 
potential risks and benefits, and required follow-up procedures per the informed consent 
process (Section 8.3 – Informed Consent). After the patient has voluntarily signed and dated 
the informed consent document, the patient will be considered screened. If a patient does 
not sign the informed consent document, then no further procedures for the clinical study 
will occur. Subjects who were screened but do not qualify for enrollment will be documented 
as ineligible on the Subject Screening Log. Patients who do not pass the eligibility 
evaluations will neither be enrolled in the study nor followed. Subjects enrolled, but with no 
device implant, will be followed through the one month follow-up only. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 68 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Those subjects who sign and date the informed consent document, and meet all of the study 
eligibility criteria will be eligible for enrollment into the clinical study.  
For those subjects who are enrolled, baseline information will include the following and be 
recorded on the appropriate eCRFs 
• Patient Demographics 
• Preoperative Assessments/Medical History 
• Stent Graft Sizing 
• Device Selection 
The following should take place prior to the implant procedure: 
• Informed consent. 
• Demographic data. 
• Medical history. 
• Physical examination including left arm assessment and bilateral upper extremity 
blood pressures and pulses (within 1 month of index procedure). 
• Neurological exam to establish neurological baseline, conducted by a neurologist 
and including: 
o NIH Stroke Scale Assessment 
o Modified Rankin Score 
o Mini Mental Status Exam 
o Additional Neurological Testing that may include Visual Fields Testing and 
Gait Assessment 
• Pregnancy test (for female patients of childbearing potential). Test must be 
completed at the time of screening, prior to the index procedure. Results must be 
negative. 
• Laboratory tests (completed within 14 days prior to the index procedure) to 
include: WBC (not differential), serum creatinine, and INR for patients taking 
Coumadin preoperatively.  
• CT or MRA with contrast of the chest, abdomen and pelvis (celiac to external iliac 
arteries) completed within 4 months prior to the index procedure.  
o A copy of this CTA imaging (electronic or otherwise) should be submitted to 
the Medtronic Vascular Clinical Study Team. Pre-operational CT scan will be 
reviewed by an independent physician reviewer in order to check that aortic 
anatomy fulfills anatomical inclusion/exclusion criteria 
• Contrast-enhanced computerized tomography angiography (CTA) scan 
(head/neck) with 3-D reconstruction for evaluation of intracranial circulation to 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 69 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
determine patient anatomic suitability for the Valiant Mona LSA Thoracic Stent 
Graft System implantation. 
• Ultrasound of the LSA and carotid vessels.  
The subject will be considered enrolled after arterial access is achieved and the Valiant 
Mona LSA Thoracic Stent Graft System has been introduced into the vasculature.  
 
9.3 STENT GRAFT IMPLANT PROCEDURES 
All investigators will read, understand and be trained to The Valiant Mona LSA Thoracic 
Stent Graft System IFU prior to initiation of the procedure. The IFU which is packaged with 
the device must be followed for implantation of the stent graft system. 
The following events will be performed and documented in the medical records and in the 
Index Procedure eCRFs as applicable: 
• Information pertaining to any preoperative adjunctive procedures and data 
collected during the procedure will be recorded on the eCRF 
• The anesthesia and general surgical protocol (e.g., administration of prophylactic 
antibiotic therapy, technique for access and closure of the arterial site, use of 
systemic heparin) will be left to the discretion of the implanting physician and the 
standard medical practice at the hospital.  
• Verification of the dimensions and characterization of the DTA and pertinent 
arteries will be documented using angiography at the time of the procedure and 
prior to the insertion of the Valiant Mona LSA Thoracic Stent Graft System. Use of 
an angiographic catheter with calibrated radiopaque marking is preferred. The 
investigator will verify dimensions and characterizations of the subject’s anatomy in 
relation to the Valiant Mona LSA Thoracic Stent Graft System. Subjects who are 
found not to be candidates for the Valiant Mona LSA device, because of findings 
detected during the treatment angiogram, will be documented as such on the 
appropriate eCRFs.  
• Arterial site will be accessed per Investigator’s standard method. 
• All Mona LSA Stent Grafts used for implantation and any issues related to the device 
will be documented in the medical chart and on the eCRFs. 
• Fluoroscopic guidance will be used for placement of the stent graft throughout the 
endovascular procedure. Total fluoroscopic time and volume of contrast used will 
be documented.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 70 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• All devices should be deployed following the steps outlined in the IFU, which is 
provided with the packaged device (also Appendix A).  
•   Additional procedures performed during the treatment will be documented on the 
appropriate eCRFs. 
• Upon completion of the index procedure, a final run-off angiography should be 
performed to document the status of the Valiant Mona LSA Stent Graft device(s), 
the thoracic aorta, and the surrounding vasculature.  
o A copy of the implant procedural angiographic imaging (electronic or 
otherwise) may be requested and should be submitted to the Medtronic 
Vascular Clinical Study Team in a timely manner. 
• The estimated blood loss, number of blood units replaced, and any adverse events 
experienced during the treatment will be documented. 
• The access site will be closed as per the Investigator’s standard of care. 
Additional information to be recorded on the Index Procedure eCRF includes the following. 
• Date of hospital admission prior to the index procedure 
• Date of the index procedure 
• General procedural information 
• Success of device implantation 
• Occurrence of adverse events or technical observation 
Identification and/or serial numbers for all investigational components of the Valiant Mona 
LSA Thoracic Stent Graft System used or opened during the index procedure will be 
recorded on the Device Disposition log. Product that was opened and not used or 
damaged during the procedure must be returned to Medtronic Vascular. Refer to Appendix 
H for return instructions.  
Adverse events should be reported on the Adverse Event eCRF as specified in Section 9.9 
– Adverse Events.  
Inability to implant the Valiant Mona LSA Stent Graft following arterial access due to 
deployment issues or entrapment of the delivery system will be considered a treatment 
failure. These subjects will be followed through the 1-month follow-up time point and then 
exited from the study. 
The Adverse Event eCRF should be completed for any conversion, as appropriate. If a 
primary conversion to open repair is required during the index procedure, then the subject 
will be followed for 1 month, at which time the subject will be exited from the study.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 71 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
9.4 HOSPITAL DISCHARGE PROCEDURES 
Information pertaining to the subject’s hospital experience and discharge will be recorded 
on the Hospital Discharge eCRF. Data will include the following. 
• Date of hospital discharge 
• Duration of stay in the ICU, if applicable 
• Physical examination including left arm assessment and bilateral upper extremity 
blood pressures and pulses 
• For postoperative subjects who are clinically symptomatic or have a changed 
neurological deficit, a diffusion-weighted MRI (head/neck) will be required, in 
conjunction with: 
o Neurological exam conducted by a neurologist and will include: 
▪ NIH Stroke Scale Assessment 
▪ Modified Rankin Score 
▪ Mini Mental Status Exam 
▪ Additional Neurological Testing that may include Visual Fields Testing 
and Gait Assessment 
• Duplex ultrasound (DUS) of LSA/thoracic branch vessel 
• Chest X-Ray (performed per Investigator’s standard of care) 
• CTA w/ 3D reconstruction capabilities  
• Any other aorta-related imaging 
• Serum creatinine  
• Occurrence of adverse events 
Copies of aorta-related films (electronic or otherwise) should be submitted to the 
Medtronic Vascular Clinical Study Team in a timely manner. Images will be collected by the 
Clinical Study Team for all subjects enrolled at screening/baseline, discharge, 1-month, 6-
months, 12-months, and annually through 5 years.  
 
9.5  REQUIRED FOLLOW-UP EVALUATIONS 
Follow-up evaluations will be scheduled for 1 month (± 15 days), 6 months (-30/+56 days), 
12 months (-30 days/+56 days) and annually thereafter to 5 years post implant (-
8/+16weeks).  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 72 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
It is expected that the Investigator enrolling the subject at the participating site where the 
implantation occurred will follow the subject during the course of the study. It is the 
responsibility of the Investigator to make sure that the subject is followed and that integrity 
and accuracy of the data is maintained.  
The following tests and procedures will be included at each of these visits: 
• Physical exam including left arm assessment and bilateral upper extremity blood 
pressures and pulses 
• Adverse event assessment 
• Serum creatinine value 
• Technical observations, evaluations, and additional treatment in relation to the 
Valiant Mona LSA Stent Graft 
• For postoperative subjects who are clinically symptomatic or have a changed 
neurological deficit, a diffusion-weighted MRI (head/neck) will be required as well as: 
o A neurological exam conducted by a neurologist which will include: 
▪ NIH Stroke Scale Assessment 
▪ Modified Rankin Score 
▪ Mini Mental Status Exam 
▪ Additional Neurological Testing that may include Visual Fields Testing 
and Gait Assessment 
• All related stent graft imaging (completed with date of imaging recorded) including: 
o CTA w/ 3D reconstruction capabilities at: 1 month, 6 months, 12 months, 2, 3, 4 
and 5 years. Doppler ultrasound of the LSA and carotid arteries will be required 
at each follow-up timepoint.  
o Chest X-Ray (performed per Investigator’s standard of care) 
o Any additional images requested by the physician. 
Copies of aorta-related films (electronic or otherwise) should be submitted to the 
Medtronic Vascular Clinical Study Team in a timely manner. Images will be collected by the 
Clinical Study Team for all subjects enrolled at screening/baseline, discharge, 1-month, 6-
months, 12-months, and annually through 5 years.  
Follow-up visits are scheduled for appointed times from the date of the implant procedure. 
It is important that this schedule is followed as closely as possible for all subjects. The 
Sponsor recognizes that subjects may not be able to return for follow-up visits at exactly 
the required date; therefore, a window has been created in which each visit is allowed (time 
period). Follow-up visits should be scheduled as closely as possible to the earlier part of the 
time period to allow for possible re-scheduling, preventing the visit from occurring outside 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 73 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
of the allowed window. Follow-up window timeframes are summarized in Table 9-2. All 
data required for the follow-up must be collected within the window for that scheduled 
visit, though not necessarily on the same day. 
Table 9-2: Required Post Operative Follow-Up Schedule and Windows  
Follow-Up Visit 
Window Start 
Day 
Target Day 
Window Close Day 
1 Month (± 15 days) 
15 
 30 
45 
6 Months (-30 /+56 days) 
153 
183 
239 
12 Months (-30/+ 56 days) 
335 
365 
421 
24 Months (-8/+16 weeks) 
674 
730 
842 
36 Months (-8/+16 weeks) 
1039 
1095 
1207 
48 Months (-8/+16 weeks) 
1404 
1460 
1572 
60 Months (-8/+16 weeks) 
1769 
1825 
1937 
 
9.6 UNSCHEDULED VISITS 
If a subject has a visit specifically associated with the treated disease and/or Valiant Mona 
LSA Stent Graft and this visit is not within any of the protocol specified study-related visit 
windows, data should be recorded as appropriate on the Unscheduled Follow-Up Forms 
and/or Adverse Event Case Report Form.  
 
9.7 PROTOCOL DEVIATIONS 
A protocol deviation occurs when a clinical Investigator and/or study site personnel do not 
conduct the study according to the CIP. All deviations are recorded on a Protocol 
Deviation eCRF. United States regulations (21 CFR 812.140) require that investigators 
maintain accurate, complete, and current records relating to the clinical study. This 
includes documents showing the dates and reasons for each deviation from the CIP. 
Depending upon the nature of the protocol deviation, expedited reporting and prior 
approval from Medtronic Vascular may be required. Protocol deviations should be reported 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 74 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
to your Institutional Review Board (IRB) in accordance with IRB policies and/or local laws. All 
deviations will be summarized and submitted in scheduled progress reports. 
If Medtronic Vascular finds that an investigator is not complying with the executed study 
agreements, the CIP, FDA regulations, or the requirements of the reviewing IRB, prompt 
action will be taken to secure compliance. In addition, shipment of the device may be 
stopped or the participation of the investigator may be terminated (21 CFR 812.46). 
Additional information is provided in Section 9.15 – Study Termination. 
 
9.7.1 Deviations with Expedited Reporting Requirements  
For the following types of protocol deviations (per 21 CRF 812.150), an investigator is 
required to notify Medtronic Vascular and the IRB within 5 business days of the deviation.  
• Emergency Deviation from the CIP (a deviation to protect the life or physical well-
being of a subject in an emergency). 
• Failure to obtain Informed Consent.  
Notification to Medtronic Vascular and/or the IRB should be documented and maintained 
in the clinical study file at the site and at Medtronic Vascular.  
 
9.7.2 Deviations Requiring Prior Approval  
An investigator is required to obtain prior approval from clinical study management at 
Medtronic Vascular and the IRB before initiating deviations from the CIP that affect the 
scientific soundness of the plan, or the rights, safety, and welfare of the subjects (non-
emergent situation). However, prior approval is not required in situations where 
unforeseen circumstances are beyond the investigator’s control, e.g., subject did not 
attend scheduled follow-up visit, laboratory test was performed incorrectly, and test 
equipment did not operate properly. 
 
9.7.3 Non-Urgent Deviations  
Protocol deviations which do not have the urgency associated with expedited notification 
or prior Medtronic Vascular/ IRB approval (as discussed in Sections 9.7.1 and 9.7.2) will be 
reported upon discovery, such as during completion of eCRFs or a monitoring visit.  
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 75 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9.8 TECHNICAL OBSERVATIONS 
A technical observation is a defect, malfunction, or failure of the Valiant Mona LSA 
Thoracic Stent Graft System to function according to its design intent. This includes, but is 
not limited to, migrations and device access difficulties. Technical observations may or 
may not be related to an adverse event. Technical observations that are not associated 
with an adverse event will be reported on the appropriate eCRF (e.g. Follow-Up Imaging 
Form, Procedure Form). If an adverse event occurred as a result of the technical 
observation, then the appropriate adverse events forms must be completed as well. Refer 
to Appendix D for definitions for technical observations. 
 
9.9 ADVERSE EVENTS 
An adverse event is defined as any untoward medical occurrence or worsening of an 
existing condition in a subject that occurs following enrollment. All adverse events that 
meet the study definition noted above will be reported to the Sponsor and documented on 
the Adverse Event Form and in the subject’s medical records. Refer to Appendix C for 
adverse event definitions. 
Potential (anticipated) adverse events that may be associated with thoracic aortic stent 
graft procedures are listed in Section 15 - Risk Analysis. Adverse events will be reported to 
Medtronic Vascular on the Adverse Event eCRF.  
Clinical events that are inherent to a surgical procedure and expected to occur in most 
subjects for a projected duration are considered unavoidable. Such events include, but are 
not limited to, those listed in Table 9-3. These events are not required to be reported as 
adverse events during this study. 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 76 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Table 9-3: Expected and Unavoidable Adverse Events Related to the Surgical Procedure 
Description of the Event 
Time Frame from the Index Procedure 
Endoleaks observed and resolved during the 
index procedure 
Resolved by the time the subject leaves 
the OR 
Anesthesia-related nausea and/or vomiting 
Within 24 hours  
Low-grade fever (< 100° F or < 37.8° C)  
Within 48 hours 
Back pain related to laying on OR table 
Within 72 hours 
Incisional pain (pain at access site) 
Within 72 hours 
Sleep problems or insomnia 
Within 72 hours 
Mild to moderate bruising or ecchymosis 
Within 168 hours 
9.10 PATIENT DEATH 
The investigator is responsible for reporting the death of a subject to Medtronic Vascular 
and the IRB. The procedures and reporting timeframes detailed in Section 10 – Adverse 
Event Definitions and Expedited Reporting must be followed. All deaths will be reviewed 
and adjudicated by the Clinical Events Committee (CEC).  
Patient deaths must be documented on the Study Exit Form. A copy of the dictated death 
summary report death certificate, and autopsy report (if performed) should be sent to 
Medtronic Vascular. If a death occurs at a non-investigational site, it is the investigative 
center’s responsibility to attempt to retrieve information about the death. If the death 
does not occur in an institution, then the investigator must submit a summary of the 
known events surrounding the death.  
All subject deaths will be classified according to the following definitions of mortality.  
Aorta-Related Mortality 
Any death occurring within 30 days from either the index procedure or any 
secondary endovascular procedure intended to treat the disease will be considered 
Aorta-Related Mortality (ARM) unless there is evidence to the contrary. 
Additionally, deaths occurring as a consequence of any procedure intended to treat 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 77 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
the targeted disease, aneurysm rupture, or a conversion to open repair will also be 
considered as ARM. 
Ultimate adjudication of relatedness of death will be made by the CEC. Excluded 
from ARM designation are deaths related to disease in anatomic areas other than 
the targeted segment treated by the Valiant Mona LSA Thoracic Stent Graft 
System. 
Perioperative Mortality 
Any death that occurs intraoperatively or within 30 days of the index procedure will 
be considered perioperative mortality. In addition, any death that occurs beyond 30 
days while the patient is still hospitalized following the index procedure will be 
considered a perioperative death. 
In the event of a patient death, the Valiant Mona LSA Stent Graft should be explanted 
(when feasible) and returned to Medtronic Vascular for analysis. Refer to Section 9.11 - 
Explanted Devices.  
 
9.11 EXPLANTED DEVICES 
All explanted devices should be returned to Medtronic Vascular for analysis. Information 
pertaining to the explant procedure should be recorded on the Explant Form. If a product is 
explanted and not returned to Medtronic Vascular, an explanation should be provided. The 
final disposition of the device must be recorded on the device accountability log. Relevant 
information should also be recorded on associated case report forms, e.g., Adverse Event 
and Study Exit Form. 
Detailed instructions are provided in Appendix H for explant of the device and its return. 
An overview of the explant procedure follows. 
• Notify Medtronic Vascular when an explant has occurred. Medtronic Vascular will 
provide a shipping container for the explanted product, which includes 
instructions and a return shipping label. 
• Before the device is explanted, if possible, obtain an in situ photograph of the 
stent graft. At the time of removal, care should be taken to avoid excessive 
manipulation with metallic instruments at the proximal and distal fixation sites. 
Leave the stent graft as intact as possible and avoid deforming the device. All 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 78 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
efforts should be taken to preserve the connection between the MSG and the 
BSG during explant 
• When the explant is performed as part of an autopsy or a postmortem 
procedure, the device should be carefully excised with at least 1 cm of host 
tissue adjacent to the proximal and distal fixation sites. Do not disturb the inside 
surface of the stent graft. 
• Record the location of the site of the tissue removal relative to the position of 
the stent graft. 
• If possible, immediately after its removal, make photographic records of the 
explanted device and the explant site. 
• Clearly identify all components relative to surgical placement and orientation. 
Identify the proximal and distal ends. The anterior portion of the stent graft 
should also be labeled. Surgical clips and sutures can be used to label the 
explanted device. A complete record of labeling methodology should be made at 
the time of the explant procedure and be included with the explanted product 
and any relevant reports. 
• Complete the Explant Form. Labels are provided in the explant kit. 
• The subject undergoing explant as a secondary procedure will be followed for 1 
month subsequent to removal of the device. 
• A summary of the explant findings will be provided to the investigator. 
 
9.12 STUDY EXIT 
The Study Exit Form should be completed at the time a subject is exited from the study. A 
subject will be considered to have exited from the study for any of the following reasons. 
• Subject completes follow-ups required by the investigational plan. 
• Subject dies. 
• Subject requests to be withdrawn. 
• Physician requests that patient be withdrawn to protect the welfare of the 
patient. 
• Subject is lost to follow-up. 
• Other (specify). 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 79 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
A subject may elect to withdraw from the study at any time. The subject should notify the 
investigator. The investigator and research staff should encourage all subjects to return 
for required follow-up visits. Every attempt must be made to ensure all subjects complete 
the follow-up visit schedule. For subjects who fail to appear for a scheduled study visit, the 
site must contact the subject in a timely manner to reschedule the visit and associated 
required evaluations within the subject’s window, if possible. 
The efforts to obtain follow-up information must include, at a minimum, three (3) attempts 
to make contact via telephone. If contact via phone is not successful, a certified letter from 
the Principal Investigator must be sent to the subject’s last known address. When possible, 
public records should be searched to identify vital status. All contact efforts to obtain 
follow-up must be documented in both the subject’s medical records and on the eCRFs.  
 
9.13 SUBJECT CONFIDENTIALITY 
Subject confidentiality will be maintained throughout the clinical study to the extent 
permitted by law. That is, every attempt will be made to remove subject identifiers from 
clinical study documents. For this purpose, a unique subject identification code (site 
number, subject number and subject initials) will be assigned and used to allow 
identification of all data reported for each subject. This will also ensure that the 
information can be tracked back to the source data.  
Study data may be made available to third parties, e.g., in the case of an audit performed by 
regulatory authorities, provided the data are treated confidentially and that the subject’s 
privacy is guaranteed. The identity of a subject will never be disclosed in the event that 
study data are published. 
Medtronic Vascular recommends that the study sites comply with the subject 
confidentiality provisions of the Health Insurance Portability and Accountability Act 
(HIPAA) issued by the U.S. Department of Health and Human Services (HHS). Sites should 
maintain patient privacy in accordance to federal regulations (45 CFR Parts 160 and 164), 
local regulations, and institutional requirements. 
 
9.14 DEVICE ACCOUNTABILITY 
Medtronic Vascular is responsible for the availability and traceability of all investigational 
products. Documentation is required at each step of the process via a device disposition 
log. Investigational product will be reconciled on a regular basis.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 80 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
The investigator also is required to maintain adequate records of the receipt and 
disposition of all investigational devices. A device disposition log will be provided for this 
purpose.  
Explanted or abandoned product should be returned to Medtronic Vascular (see Appendix 
H). All unused product must be returned to Medtronic Vascular at the close of the study. 
 
9.15 STUDY TERMINATION 
Medtronic Vascular and/or the US FDA have the right to terminate this study at any time 
and remove all study materials from the site. A study may be terminated for any of the 
following reasons. 
• Unsatisfactory rate of patient enrollment or compliance to eligibility criteria. 
• Repeated noncompliance with the investigational plan. 
• Inaccurate, incomplete, and/or untimely submission of data. 
• The rate or severity of adverse events in this study or other similar studies indicates 
a potential health hazard to the subjects caused by the device. 
• Inadequate accountability of the investigational device. 
 
9.16 STUDY CLOSURE 
Upon completion (when all subjects enrolled have completed the 5-year follow-up visit or 
previously exited the study, and the eCRFs and queries have been completed) or 
termination (closure that occurs prior to meeting defined endpoints) of the study, 
Medtronic Vascular and/or its designees will notify the site. Study closeout visits will be 
performed. All unused study devices and any unused study materials and equipment will be 
collected and returned to Medtronic Vascular and/or its designees. The monitors will 
ensure that the investigator’s regulatory files are up to date and complete and that any 
outstanding issues from previous visits have been resolved. Other issues that will be 
reviewed at this visit include: discussing record retention requirements, device 
accountability, possibility of site audits, publication policy, and notifying the IRB of study 
closure, etc. 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 81 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
10. ADVERSE EVENT DEFINITIONS AND EXPEDITED REPORTING 
A list of potential adverse events is provided in Section 15 - Risk Analysis. Adverse event 
definitions and reporting schedules are defined in the following sections.  
10.1 DEFINITIONS 
Adverse Event 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, whether or not 
related to the investigational medical device after the patient was enrolled in the 
study. 
The events identified as expected clinical procedure events (Table 9-3) will not be 
considered adverse events. Specific adverse event definitions are provided in 
Appendices B – C. 
Major Adverse Event 
Major adverse events include the occurrence of any of the following and are defined 
in Appendix B. 
• All-Cause Mortality 
• Myocardial Infarction 
• Paraplegia 
• Renal Failure 
• Stroke 
• Left Arm/Hand Ischemia 
Serious Adverse Event 
A serious adverse event is an adverse event that: 
• Led to a death. 
• Led to a serious deterioration in the health of the subject that resulted in: 
a. a life threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function, or 
c. in-patient hospitalization or prolongation of existing hospitalization 
d. medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function. * 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 82 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
* Planned hospitalization for a pre-existing condition, or a procedure required by 
the clinical investigational plan, without serious deterioration in health, is not 
considered a serious adverse event.  
* An observational, overnight hospital admission < 24 hours in duration does not 
qualify an adverse event as a serious adverse event. 
Unanticipated Adverse Device Effect 
An unanticipated adverse event is defined as 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.  
 
10.2 EXPEDITED ADVERSE EVENT REPORTING  
Investigators are responsible for reporting all adverse events to Medtronic Vascular as 
described in Section 9.9 – Adverse Events. The investigator should follow the reporting 
requirements of the reviewing IRB for all adverse events (including serious events). In 
addition, Medtronic requires that the following timeframes be used for the reporting of 
adverse events.  
Adverse Events 
The investigator must report to Medtronic Vascular any adverse event as soon as possible. 
In addition, the investigator must report the adverse event to the reviewing IRB according 
to its policies and procedures. 
Information should be submitted on the Adverse Event eCRF.  
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files. It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well. 
Serious Adverse Events 
The investigator must report to Medtronic Vascular any serious adverse event as soon as 
possible, but in no case later than 3 working days after the investigator first learns of the 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 83 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
event. In addition, the investigator must report the serious adverse event to the reviewing 
IRB according to its policies and procedures. 
Information should be submitted on the Adverse Event eCRF. All relevant source 
documentation should be faxed to Medtronic. 
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files. It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well. 
Unanticipated Adverse Device Effect 
The investigator must report to Medtronic Vascular any unanticipated adverse device 
effect as soon as possible, but in no case later than 10 working days after the investigator 
first learns of the event. The investigator’s report to the reviewing IRB must be completed 
within 10 working days of the investigator’s knowledge of the event (per 21 CFR 812.150).  
Information should be submitted on the Adverse Event eCRF. All relevant source 
documentation should be faxed to Medtronic Vascular Clinical Trial Safety Department at 
(651) 367-0278. 
Documentation of the IRB and Medtronic notification should be maintained in the site’s 
clinical study files. It is recommended that acknowledgement of receipt from the IRB be 
maintained in the study file as well.  
Questions about reporting of adverse events may be directed to the Valiant Mona LSA 
Thoracic Stent Graft System clinical study team. 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 84 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11. DATA MANAGEMENT PROCEDURES 
Medtronic Vascular will oversee all data management functions. Medtronic Vascular will be 
responsible for database development, system maintenance, user training, data queries, 
and report generation.  
 
11.1 CASE REPORT FORMS 
Medtronic Vascular will use an electronic data capture (EDC) system to collect patient 
data. The eCRFs are the primary component of EDC. Training on use of the system will be 
provided to the study site personnel. Instructions for completion of the eCRFs also will be 
provided. 
The eCRFs must be completed, saved, and approved via electronic signature by the 
Investigator using a unique ID and password. This ID and password are for the use of the 
investigator only and may not be used by any other person. Because of the potential for 
errors or inaccuracies in transcribing data into eCRFs, source documentation must be 
maintained in each subject’s hospital chart and/or electronic medical record. The eCRFs 
and source documentation must be available at all times for inspection by the study 
monitors or regulatory inspectors. 
Changes made to eCRFs will be electronically recorded in a complete audit trail that cannot 
be changed, but can be accessed by authorized personnel at any time. All data are 
transmitted via the Internet in an encrypted fashion. When received at the server site, the 
data are decrypted and stored. Data can be extracted for Medtronic Vascular review and 
analysis at any time. 
 
11.2 SOURCE DOCUMENTATION 
IDE regulations require Investigators to maintain records of each subject’s case history and 
exposure to the device. Investigators should maintain source documents to support the 
data recorded on the study case report forms. Source documents should be made available 
as required by Medtronic Vascular and/or its designees and/or regulatory inspectors during 
monitoring visits and/or audits or inspections.  
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 85 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11.3 TRANSMISSION OF DATA  
Required data will be recorded on the appropriate eCRF at the time of or as soon as 
possible after the patient visit. The eCRFs and any requested supporting source 
documents must be de-identified and sent to Medtronic Vascular and/or retrieved from 
the investigator during monitoring visits. Questions about completion of the eCRFs may 
be directed to the Valiant Mona LSA Thoracic Stent Graft System clinical study team. 
 
11.4 DATA QUERIES  
Any discrepancies in data observed during a monitoring visit or during a review of the data 
will be queried by Medtronic Vascular or its designee and should be resolved by the 
investigational site staff and investigator in a timely manner. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 86 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
12. MONITORING AND AUDITING PROCEDURES 
12.1 CLINICAL STUDY SPONSOR AND MONITORS 
Study monitoring and auditing will be performed by appropriately trained personnel 
appointed by the study Sponsor to ensure that the investigation is conducted in accordance 
with Medtronic requirements and applicable laws and regulations, i.e., US FDA IDE 
regulations. 
 
A monitor is an individual designated by a sponsor or contract research organization to 
oversee the progress of an investigation. The monitor may be an employee of a sponsor or 
a consultant to the sponsor, or an employee of or consultant to a contract research 
organization.  
 
12.2 MONITORING METHODS 
Monitoring of the clinical study will be a continuous, interactive process to ensure that 
high-quality data are obtained in compliance with the CIP and regulatory requirements. 
Monitoring functions will be conducted by Medtronic Vascular or designee. Specific 
monitoring requirements are detailed in the Valiant Mona LSA Thoracic Stent Graft 
System Monitoring Plan (maintained in the Medtronic Vascular clinical study project files). 
Frequent communication will be maintained with each investigational site to keep both the 
clinical center and Medtronic Vascular up-to-date and aware of the study progress. 
Electronic case report forms will be reviewed for completeness and accuracy.  
On-site monitoring of all study centers will be frequent enough (at a minimum annually) to 
assure continued integrity and acceptability of the data. Accuracy of data reported on case 
report forms will be verified by comparison to source documents. Follow-up 
correspondence will be provided to the clinical study personnel at each site. Corrective 
action will be taken to resolve any issues of noncompliance. If Medtronic Vascular finds 
that an investigator is not complying with the executed study agreements, the CIP, FDA 
regulations, or the requirements of the reviewing IRB, then prompt action will be taken to 
secure compliance. In addition, shipment of the device may be stopped or the participation 
of the investigator may be terminated (21 CFR 812.46). Additional information is provided 
in Section 9.15 – Study Termination. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 87 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
12.3 MONITORING VISITS 
Scheduled visits to the clinical investigational site will occur at the following intervals: prior 
to the start of the clinical trial (pre-study qualification visit, if applicable), at initiation of the 
study (at first implant or shortly thereafter), interim visits throughout the clinical study as 
needed, annually, and upon completion of the clinical study. 
An on-site audit may be completed periodically throughout the study at each clinical site by 
Medtronic Vascular or an independent third party group. The purpose of the audit will be to 
ensure compliance to the investigational plan and regulatory requirements.  
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 88 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
13. RECORDS AND REPORTS 
Throughout the course of this clinical study, Medtronic Vascular, the investigators, and 
reviewing IRBs are responsible for the records and reports detailed in the following 
sections. Additional information is provided in the US FDA IDE regulations (21 CFR 812.140 
and 21 CFR 812.150).  
 
13.1 INVESTIGATOR RECORDS 
Records must be maintained by the investigator in compliance with national regulations. 
Investigator records are subject to regulatory inspection (and Medtronic Vascular) and 
copying, and must be retained for a period of 2 years after the investigation is completed 
or terminated, or, 2 years after the records are no longer required to support the 
application to market the device (whichever date is later). 
The investigator is responsible for the preparation (review and signature) and retention of 
the records cited below. 
• All correspondence with another investigator, IRB, Medtronic Vascular, a 
monitor, or FDA, including required reports and study documents which pertain 
to the investigation. 
• Records of receipt, use, and final disposition of a device.  
• Records of each subject's case history and exposure to the device. Case 
histories include the case report forms and supporting source data (signed and 
dated informed consent forms, medical records, e.g., progress notes of the 
physician, patient’s hospital chart, nursing notes).  
• The clinical investigational plan, with documents showing the dates of and 
reasons for each deviation from the protocol.  
• Any other records that FDA requires to be maintained by regulation or by 
specific requirement for a category of investigations or a particular 
investigation. 
13.2 INVESTIGATOR REPORTS 
The investigator is responsible for the preparation and submission of the reports cited in 
Table 13-1. Reports must be prepared in complete, accurate and timely manner. These 
reports may be subject to regulatory inspection (and inspection by Medtronic Vascular) 
and copying, and the retention requirements described above for Investigator Records. In 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 89 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
addition to the reports listed in the following table, FDA or the reviewing IRB may request 
reports pertaining to any aspect of the clinical study. 
Table 13-1: Investigator Reporting Responsibilities  
REPORT 
SUBMIT TO 
DESCRIPTION/CONSTRAINTS 
Unanticipated 
Adverse Device 
Effects 
Sponsor and IRB 
The report must be submitted to Medtronic Vascular within 3 
working days after the investigator first learns of the effect.  
Notification to the IRB should be made according to the reporting 
requirements of the reviewing IRB, but no later than 10 working 
days after the investigator first learns of the effect. 
Serious Adverse 
Events 
Sponsor and IRB 
The report must be submitted to Medtronic Vascular within 3 
working days after the investigator first learns of the event.  
Notification to the IRB should be made according to the reporting 
requirements of the reviewing IRB. 
Adverse Events  
Sponsor and IRB 
The report must be submitted to Medtronic Vascular as soon as 
possible after the investigator first learns of the event.  
Notification to the IRB should be made according to the reporting 
requirements of the reviewing IRB. 
Withdrawal of IRB 
Approval 
Sponsor 
The investigator must report a withdrawal of the reviewing 
authority within 5 working days.  
Progress Report 
Sponsor, IRB, and 
Monitor 
The investigator must submit this report at least annually for the 
duration of the study. 
Deviation from 
Investigation Plan 
(Emergency) 
Sponsor and IRB 
Notification must be made within 5 working days if the deviation 
was made to protect the life or physical well-being of a subject. 
Deviation from 
Investigation Plan 
(Other – Non-
Emergent) 
Sponsor and IRB 
If the deviation may affect the scientific soundness of the plan or 
the rights, safety and welfare of the subjects (and is not an 
emergency), then the deviation must be approved by Medtronic 
Vascular and the reviewing authority prior to its implementation. 
If the deviation does not affect these issues (study soundness, 
rights, safety, etc.) then only Medtronic Vascular must approve it, 
(except in cases which are beyond the control of the 
investigator—see Section 9.7 – Protocol Deviations). 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 90 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Table 13-1: Investigator Reporting Responsibilities  
REPORT 
SUBMIT TO 
DESCRIPTION/CONSTRAINTS 
Failure to Obtain 
Informed Consent 
Sponsor and IRB 
The Investigator must notify Medtronic Vascular and the 
reviewing authority within 5 working days after device use. The 
report must include a brief description of the circumstances 
justifying the failure to obtain informed consent. 
Final Report 
Sponsor and IRB 
This report must be submitted within 3 months after termination 
or completion of the investigation. 
13.3 SPONSOR RECORDS 
Medtronic Vascular will maintain the following study-related records. 
• All correspondence with another sponsor, a monitor, an investigator, an IRB, or 
FDA, including required reports.  
• Records of shipment and disposition of the investigational device.  
• Signed investigator agreements including the financial disclosure information 
required to be collected under 21 CFR 812.43 in accordance with 21 CFR 54.  
• Records concerning adverse events related to the device (whether anticipated 
or unanticipated) and complaints.  
• Any other records that FDA requires to be maintained by regulation or by 
specific requirement for a category of investigation or a particular investigation. 
 
13.4 SPONSOR REPORTS 
Medtronic Vascular is responsible for the reports cited in Table 13-2. These reports are 
subject to regulatory retention and inspection requirements. In addition to the reports 
listed in the following table, FDA or the reviewing IRB may request reports pertaining to 
any aspect of the clinical study. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 91 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Table 13-2: Medtronic Vascular Reporting Responsibilities 
REPORT 
SUBMIT TO 
DESCRIPTION 
Unanticipated Adverse 
Device Effects 
Regulatory authorities and all 
participating IRBs and 
investigators 
Medtronic Vascular will report on unanticipated 
adverse event within 10 working days after 
receiving notice of the effect. 
Informed Consent 
Regulatory authorities 
Medtronic Vascular will submit a copy of any 
report from an investigator of use of the device 
without obtaining informed consent within 5 
working days of receipt of notice of such use. 
Withdrawal of IRB 
Approval 
IRBs, investigators, and 
regulatory authorities, as 
appropriate 
Notification will be made within 5 working days 
after receipt of the withdrawal of approval. 
Withdrawal of Regulatory 
Approval 
All IRBs and investigators 
Notification will be made within 5 working days 
of receipt of notice of the withdrawal of 
approval. 
Current Investigator List 
Regulatory authorities 
Medtronic Vascular will submit at 6-month 
intervals (starting 6 months after FDA approval 
of the IDE). 
Progress Report 
Regulatory authorities and IRBs  
A progress report will be submitted at least 
annually. 
Recall and Device 
Disposition 
Regulatory authorities, IRBs, 
and investigators 
Notification will be made within 30 working days 
and will include the reasons for any request that 
an investigator return, repair or otherwise 
dispose of any devices. 
Final Report 
Regulatory authorities, IRBs, 
and investigators 
Medtronic Vascular will notify reviewing 
authorities within 30 working days of the 
completion or termination of the investigation. A 
final report will be submitted within 6 months of 
completion or termination. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 92 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
14. STUDY COMMITTEES 
14.1 CLINICAL EVENTS COMMITTEE 
A Clinical Events Committee (CEC) is a group of physicians independent of the clinical 
study with expertise and experience in the area of DTA stent grafts. The members may be 
interventional cardiologists, vascular surgeons, cardiothoracic surgeons, interventional 
radiologists, or neurologists. The CEC will review and adjudicate all major adverse events 
(MAEs) as defined in the clinical investigational plan. Any unanticipated adverse device 
events (UADEs) will be reviewed and adjudicated by the Clinical Events Committee (CEC). 
In addition, the CEC will review and adjudicate specific adverse events identified by the 
Sponsor or an independent Data Safety Monitoring Board (DSMB) that occur during the 
course of the trial. The CEC will review events when Medtronic Vascular personnel forward 
the relevant documentation to the members. 
A charter will be developed that will detail the operations of the committee. Results of the 
adjudication process will be recorded by the CEC members on the appropriate CEC Event 
Adjudication Forms. 
 
14.2 DATA SAFETY MONITORING BOARD  
The DSMB is composed of at least 5 members, consisting of 4 physicians from the fields of 
vascular, cardiovascular surgery, interventional radiology, interventional cardiology, or 
neurology and 1 biostatistician, who are not directly involved in the conduct of the study. 
The DSMB will be convened when four (4) subjects have completed follow-up through the 
30-day visit and this data is fully monitored. Based on the available subject safety data, the 
DSMB may recommend that Medtronic Vascular continue enrollment in the study as per 
the approved investigational plan, modify the clinical study, or stop study enrollment in 
accordance with parameters previously agreed upon between the DSMB and Medtronic 
Vascular. All final decisions, however, regarding study modifications, rest with Medtronic 
Vascular.  
After the first DSMB meeting, subsequent meetings of the DSMB will be based on the 
DSMB’s guidance, and this will be outlined in the DSMB charter.   
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 93 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
14.3 INDEPENDENT PHYSICIAN REVIEWER 
The Independent Physician Reviewer will review imaging prior to subject enrollment into 
the study in order to determine that each subject meets the anatomical requirements set 
forth in this investigational plan.  
Further details will be outlined in the Independent Physician Reviewer Manual of 
Operations. 
14.4 IMAGING CORE LAB 
An imaging core lab will be established to independently analyze images based on the 
imaging protocol/core lab guidelines. Imaging guidelines will be provided in the 
investigational site file. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 94 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
15. RISK ANALYSIS 
15.1 POTENTIAL RISKS 
Following is a list of potential (expected) risks that may be associated with use of the 
Valiant Mona LSA Thoracic Stent Graft System. The occurrence of the listed complications 
may lead to a repeat endovascular intervention and/or open surgical repair. Since the 
Valiant Mona LSA Thoracic Stent Graft System is an investigational device, the risks are 
not entirely known, but are believed to be similar to those that are associated with the 
existing endovascular devices in clinical use or commercially available as well as the 
standard surgical repair of DTAs. The long-term effectiveness of endovascular repair has 
not been established. The potential adverse events/complications are listed in Table 15-1. 
 
Table 15-1: Potential Adverse Events/Complications Associated with Use of the Valiant Mona 
LSA Thoracic Stent Graft System  
Access failure 
Endoleaks 
Procedural bleeding 
Access site complications (e.g., 
spasm, trauma, bleeding, rupture, 
dissection) 
Excessive or inappropriate 
radiation exposure 
Prosthesis dilatation 
Adynamic ileus 
Extrusion/erosion 
Prosthesis infection 
Allergic reaction (to contrast, anti-
platelet therapy, stent graft 
material) 
Failure to deliver the stent graft 
Prosthesis rupture 
Amputation 
False lumen perfusion  
Prosthesis thrombosis 
Anesthetic complications 
Femoral neuropathy  
Pseudoaneurysm 
Aneurysm or false lumen 
expansion 
Fistula (aortobronchia, 
aortoenteric, 
aortoesophogeal, arteriovenous, 
lymph) 
Pulmonary edema 
Aneurysm rupture 
Gastrointestinal 
bleeding/complications  
Pulmonary embolism 
Angina 
Genitourinary complications 
Reaction to anesthesia 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 95 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Arrhythmia 
Hematoma 
Renal failure 
Arterial stenosis 
Hemorrhage/bleeding 
Renal insufficiency 
Atelectasis 
Hypotension/hypertension 
Re-operation 
Blindness 
Infection or fever 
Respiratory depression or failure 
Bowel ischemia/infarction 
Insertion or removal difficulty 
Sepsis 
Bowel necrosis 
Intercostal pain 
Seroma 
Bowel obstruction 
Intramural hematoma 
Shock 
Branch vessel occlusion 
Leg edema/foot edema 
Spinal neurological deficit 
Buttock claudication 
Lymphocele 
Stent graft material failure 
(including breakage of the metal 
portion of the device) 
Cardiac tamponade 
Myocardial infarction 
Stent graft migration 
Catheter breakage 
Neuropathy 
Stent graft misplacement 
Cerebrovascular accident 
(CVA)/Stroke 
Occlusion – Venous or Arterial 
Stent graft occlusion 
Change in mental status 
Pain/reaction at catheter insertion 
site 
Stent graft twisting or kinking 
Coagulopathy 
Paralysis 
Transient ischemic attack (TIA) 
Congestive heart failure 
Paraparesis 
Thrombosis 
Contrast toxicity 
Paraplegia 
Tissue necrosis 
Conversion to surgical repair 
Paresthesia 
Vascular ischemia 
Death 
Peripheral ischemia 
Vascular trauma 
Deployment difficulties/failures 
Peripheral nerve injury 
Wound dehiscence 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 96 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Dissection, perforation, or rupture 
of the aortic vessel & surrounding 
vasculature 
Pneumonia  
Wound healing complications 
Embolism 
Post-implant syndrome 
Wound infection 
 
Post-procedural bleeding 
 
 
All efforts will be made to minimize these risks by selecting investigators who are 
experienced and skilled in using endoluminal aortic devices and who have been adequately 
trained. Also, risk minimization activities were performed during development and design 
verification testing of the device. Activities intended to minimize risks include the 
following: 
• Investigator and study personnel training will be conducted to share information 
regarding the design of the Valiant Mona LSA Thoracic Stent Graft System, its 
application, and pre-clinical results.  
• The Investigator will adhere to eligibility criteria and screening procedures to 
ensure that appropriate patients are enrolled. 
• An Independent Physician Reviewer will review the Screening images of each 
patient to ensure that the appropriate patients are enrolled.  
• The Investigator will adhere to the Valiant Mona LSA Thoracic Stent Graft System 
Instructions for Use packaged with the device.  
• The subjects will be carefully monitored throughout the study period.  
• The Investigator will evaluate the subject adverse events during the course of the 
study.  
• Data submitted from the investigative centers will be monitored during the course 
of the study.  
• An imaging core lab will review the study related images on an ongoing basis. 
• Monitoring visits will be conducted to evaluate protocol compliance and data 
quality.  
• Safety and effectiveness data obtained during the course of the study will be shared 
with Investigators in periodic reports to increase understanding of the device and 
potential adverse events.  
• Any subject death or any device related issue will be reported to the FDA. 
• A DSMB will monitor safety outcomes and provide guidance on whether or not the 
study should continue. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 97 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Detailed study procedures are provided in Section 9 - Clinical Study Procedures. 
15.2 CLINICAL RISK BENEFIT 
In current clinical practice, the LSA is commonly covered during endovascular treatment 
for pathologies of the thoracic arch occurring close to the LSA. In some cases, prior 
revascularization either as a bypass or transposition of the LSA may be required. This 
usually requires a separate hospitalization two to three days prior to the endovascular 
procedure. Additionally, a proximal subclavian ligation or embolization to prevent type II 
endoleak may also be undertaken. As with any surgical procedure, this revascularization 
procedure carries some risk. Current literature places the risk of phrenic nerve damage at 
approximately 4% and a low associated risk of mortality. 
As an off-the-shelf system, the Valiant Mona LSA Thoracic Stent Graft System serves an 
unmet clinical need by providing a complete endovascular solution for perfusion of the LSA 
as a part of TEVAR, thereby reducing one endovascular and one surgical procedure to a 
single endovascular procedure. The implication of this for the Valiant Mona LSA Thoracic 
Stent Graft System is that if perfusion of the LSA fails with the proposed device, the 
outcome would then resemble the current clinical standard of care of covering the LSA. As 
in current cases in which the LSA is covered, revascularization would still be an option if the 
patient presented with issues associated with the occlusion. 
 
15.3 POTENTIAL BENEFITS 
The potential benefits of the Valiant Mona LSA Thoracic Stent Graft Systems have not 
been documented; nevertheless, they are expected to be similar to those associated with 
endovascular stent graft systems currently in clinical trials or commercially available. 
Endovascular treatment of DTA has been shown to be an effective, less invasive procedure 
that may result in a reduced rate of early mortality and comorbidities associated with open 
surgical repair.22-26 Stent graft repair also provides a treatment option for patients who 
would not otherwise be eligible for surgical repair. Additional potential benefits include the 
following. 
• Reduced operating room and anesthesia time 
• Reduced requirement for blood transfusions 
• Shorter time in intensive care 
• Shorter length of hospital stay 
• Shorter recovery time and return to activities of daily living 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 98 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Preservation of the LSA without the need for a surgical revascularization 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 99 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
16. PUBLICATION POLICY 
Publications based on the results of the Evaluation of the Valiant Mona LSA Thoracic Stent 
Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections study will 
follow the process outlined in the Clinical Research Agreement. A publication committee 
may be formed to oversee the preparation of manuscripts and identify first authors and 
writers for primary and ancillary publications of the study results.  
At the conclusion of the study, a multicenter manuscript may be prepared for publication in 
a peer-reviewed, scientific journal. The manuscript will be made available for review by all 
co-authors, including Medtronic Vascular personnel, prior to submission. 
Publication of the primary results from any single site experience within the study will not 
be allowed until the multicenter results are published. Exceptions to this rule will require 
the prior approval of Medtronic Vascular.  
Secondary or ancillary manuscripts also are anticipated. For the purposes of timely 
abstract presentation and publication, such publications will be delegated to the 
appropriate principal author(s). Final analysis and review of the manuscript for all 
multicenter publications will require the approval of Medtronic Vascular. 
As owners of the Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in 
Descending Thoracic Aortic Aneurysms and Chronic Dissections study database, 
Medtronic Vascular has the discretion to determine who will have access to the data. This 
includes raw as well as summary data. Complete study data, which may contain health 
information that could be identified with a subject, will be made available only for study-
related/business-related activities, or to regulatory authorities and other government 
bodies.  
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 100 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
17. INSURANCE 
Medtronic Vascular has umbrella insurance in an amount common in the medical device 
industry to cover significant exposures. Medtronic Vascular will comply with local 
regulatory requirements concerning insurance coverage.