Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia
Phase: NA
Conditions: Incisional Hernia
Sponsor: Medtronic - MITG

ProGrip Self-Gripping Polyester Mesh (POETRY) 
Clinical Investigation Plan  
 
MDT17048POETRY 
Version 4 – 25 Sep 2020 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  
POETRY Study - PrOGrip™ Self-gripping Polyester 
Mesh Prospective Embedded REgisTRY for 
Abdominal Wall Sutureline Reinforcement in 
Patients Undergoing Midline Laparotomy to 
Prevent Incisional Hernia 
Clinical Investigation Plan Identifier 
MDT17048POETRY 
Study Product Name 
ProGrip™ Self-gripping Polyester Mesh 
Sponsor 
 
Medtronic, Covidien LP, MITG Surgical Innovations 
555 Long Wharf Drive  
New Haven, CT 06511 USA 
Local Sponsor 
Medtronic, Sofradim Production 
116 avenue du Formans 
01600 Trevoux France 
Document Version 
4.0  
Version Date 
25 Sep 2020 
Lead Principal Investigator(s) 
 
 
 
 
Confidentiality Statement 
 
 
 
 
 
Covidien LP and Sofradim Production are indirect wholly owned subsidiary of Medtronic plc 
 
 

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1. Investigator Commitment  
Study product Name 
ProGrip™ Self-gripping Polyester Mesh 
Sponsor 
 
Medtronic, Covidien LP, MITG Surgical Innovations 
555 Long Wharf Drive  
New Haven, CT 06511 USA 
Local Sponsor 
Medtronic, Sofradim Production 
116 avenue du Formans 
01600 Trevoux, France 
Clinical Investigation Plan Identifier 
MDT17048POETRY 
Version Number/Date  
4.0 – 25 Sep 2020 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and will 
make a reasonable effort to complete the study within the time designated. 
I agree to comply with International Conference on Harmonization Guidelines on Good Clinical Practice 
and ISO 14155:2020. I agree to ensure that the confidential information contained in this document 
will not be used for any purpose other than the evaluation and conduct of the clinical investigation 
without the prior written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date:  
 
 
 

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2. Table of Contents  
 
1. 
Investigator Commitment .................................................................................................. 2 
2. 
Table of Contents ............................................................................................................... 3 
3. 
Glossary .............................................................................................................................. 8 
4. 
Synopsis ........................................................................................................................... 10 
5. 
Introduction ..................................................................................................................... 16 
5.1. Background ........................................................................................................................... 16 
5.2. Purpose ................................................................................................................................. 17 
6. 
Objectives and Endpoints ................................................................................................. 17 
6.1. Objectives ............................................................................................................................. 17 
6.1.1. Primary Objective ............................................................................................................. 17 
6.1.2. Secondary Objective ......................................................................................................... 17 
6.2. Endpoints .............................................................................................................................. 18 
6.2.1. Primary Endpoint ............................................................................................................. 18 
6.2.2. Secondary Endpoints ........................................................................................................ 18 
7. 
Study Design .................................................................................................................... 18 
7.1. Duration ................................................................................................................................ 19 
7.2. Rationale ............................................................................................................................... 19 
7.3 Study Oversight ....................................................................................................................... 20 
8. 
Product Description.......................................................................................................... 20 
8.1. Manufacturer ......................................................................................................................... 21 
8.2. Packaging .............................................................................................................................. 21 
8.3. Intended Population ............................................................................................................... 21 
8.4. Product Use ........................................................................................................................... 21 
8.5. Product Training Requirements ............................................................................................... 21 
8.6. Product Receipt and Tracking ................................................................................................. 22 
8.7. Product Storage ..................................................................................................................... 22 
8.8. Product Return ...................................................................................................................... 22 
8.9. Product Accountability ............................................................................................................ 22 
9. 
Study Site Requirements ................................................................................................. 23 

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9.1 Investigator / Investigation Study Site Selection ...................................................................... 23 
9.2 Study Site Activation .............................................................................................................. 23 
9.3 Role of the Sponsor Representatives ....................................................................................... 24 
10. Selection of Subjects ........................................................................................................ 25 
10.1. 
Study Population .............................................................................................................. 25 
10.2. 
Subject Enrollment ........................................................................................................... 25 
10.3. 
Inclusion Criteria .............................................................................................................. 25 
10.4. 
Exclusion Criteria .............................................................................................................. 26 
11. Study Procedures ............................................................................................................. 27 
11.1 Schedule of Events ................................................................................................................. 27 
11.2 Data Collection ...................................................................................................................... 27 
11.3 Scheduled Follow-up Visit Windows ......................................................................................... 29 
11.4 Subject Screening .................................................................................................................. 29 
11.5 Subject Consent ..................................................................................................................... 30 
11.6 Operative Day (D0) ................................................................................................................ 31 
11.7 Scheduled Follow-up Visits ..................................................................................................... 31 
11.7.1 Post-operative course (D0) Follow up ............................................................................... 31 
11.7.2 Post-operative course (D1) Follow up ............................................................................... 31 
11.7.3 Discharge Data ............................................................................................................... 32 
11.7.4 Post-operative course, Day 8, (-/+2days) Follow up .......................................................... 32 
11.7.5 Post-operative course, Day 30, (-/+1 week) Follow up ...................................................... 32 
11.7.6 Post-operative course, 12 Months, (-1/+4 week) Follow up ................................................ 32 
11.7.7 Post-operative course, 24 Months, (-1/+4 week) Follow up ................................................ 32 
11.7.8 End of Study ................................................................................................................... 33 
11.8 Subject Questionnaires ........................................................................................................... 33 
11.9 Assessment of Efficacy ........................................................................................................... 33 
11.10 
Assessment of Safety ....................................................................................................... 34 
11.11 
Recording Data ................................................................................................................ 34 
11.12 
Deviation Handling ........................................................................................................... 35 
11.13 
Subject Exit, Withdrawal or Discontinuation ....................................................................... 36 
11.13.1 Study Exit ..................................................................................................................... 36 
11.13.2 
Screen Failure ........................................................................................................... 36 

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11.13.3 
Discontinuation .......................................................................................................... 36 
11.13.4 
Withdrawal ................................................................................................................ 36 
11.13.5 
Lost to Follow-Up....................................................................................................... 37 
11.13.6 
Mesh Removal ........................................................................................................... 37 
11.13.7 
Study Completed ....................................................................................................... 37 
12. Risks and Benefits ............................................................................................................ 37 
12.1. 
Potential Risks .................................................................................................................. 37 
12.2. 
Risk Minimization.............................................................................................................. 38 
12.3. 
Potential Benefits ............................................................................................................. 39 
12.4. 
Risk-Benefit Rationale ....................................................................................................... 39 
13. Adverse Events and Device Deficiencies .......................................................................... 39 
13.1. 
Adverse Events ................................................................................................................ 39 
13.2. 
Device Deficiency ............................................................................................................. 40 
13.3 Processing Updates and Resolution ......................................................................................... 40 
13.4 Definitions/Classifications ....................................................................................................... 40 
13.5 Reporting of Adverse Events ................................................................................................... 43 
13.5.1 
Adverse Event and Device Deficiency Classification ............................................................. 45 
13.6 Adverse Event Outcome Classification ..................................................................................... 46 
13.7 Study Contact Information ...................................................................................................... 46 
13.8 Subject Death ........................................................................................................................ 47 
13.9 Product Complaint Reporting .................................................................................................. 48 
14. Data Review Committees ................................................................................................. 48 
14.1 Safety Committee .................................................................................................................. 49 
15. Statistical Design and Methods ........................................................................................ 49 
15.1 General Aspects of Analysis .................................................................................................... 49 
15.2 Analysis Execution ................................................................................................................. 49 
15.3 Interim Analysis ..................................................................................................................... 49 
15.4 Endpoints .............................................................................................................................. 49 
15.4.1 Primary Endpoints ........................................................................................................... 49 
15.4.2 Other Endpoints .............................................................................................................. 49 
15.5 Analysis Sets ......................................................................................................................... 50 
15.6 Sample Size Determination ..................................................................................................... 50 

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15.7 Minimization of Bias ............................................................................................................... 50 
16. Ethics ................................................................................................................................ 51 
16.1. 
Statement(s) of Compliance .............................................................................................. 51 
17. Study Administration ....................................................................................................... 52 
17.1. 
Monitoring ....................................................................................................................... 52 
17.1.1 Monitoring Visits .............................................................................................................. 52 
17.2. 
Data Management ............................................................................................................ 53 
17.3. 
Direct Access to Source Data/Documents ........................................................................... 53 
17.4. 
Confidentiality .................................................................................................................. 54 
17.5. 
Liability ............................................................................................................................ 54 
17.5.1. 
Warranty ................................................................................................................... 54 
17.6. 
CIP Amendments ............................................................................................................. 54 
17.7. 
Record Retention ............................................................................................................. 54 
17.8. 
Reporting Requirements ................................................................................................... 55 
17.8.1. 
Investigator Reports .................................................................................................. 55 
17.8.2. 
Sponsor Reports ........................................................................................................ 56 
17.9. 
Publication and Use of Information .................................................................................... 57 
17.9.1. 
Transparency ............................................................................................................ 58 
17.10. 
Suspension or Early Termination ....................................................................................... 58 
17.10.1. 
Planned Study Closure ............................................................................................ 58 
17.10.2. 
Early Termination or Suspension ............................................................................. 58 
17.10.2.1. 
Study-wide termination or suspension ..................................................................... 58 
17.10.2.2. 
Investigator/ study site termination or suspension ................................................... 59 
17.10.3. 
Procedures for Termination or Suspension ............................................................... 59 
17.10.3.1. 
Medtronic-initiated and regulatory authority-initiated ............................................... 59 
17.10.3.2. 
Investigator-initiated .............................................................................................. 59 
17.10.3.3. 
Ethics committee-initiated ...................................................................................... 60 
18. References ....................................................................................................................... 61 
19. Appendices ....................................................................................................................... 63 
19.1. APPENDIX A: List of Investigators and Institutions .................................................................. 63 
19.2. APPENDIX B: Instructions for Use .......................................................................................... 64 
19.3. APPENDIX C: Financial Statement .......................................................................................... 67 

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19.4. APPENDIX D: Subject Forms .................................................................................................. 67 
19.5. APPENDIX E: Subject Enrollment Decision Tree ...................................................................... 68 
20. Version History ................................................................................................................. 69 
 
Table 1: Materials in contact with tissues and/or body fluids ................................................................ 20 
Table 2: Schedule of Events .............................................................................................................. 27 
Table 3: Data collection and study procedure requirements at subject visits ......................................... 29 
Table 4: Adverse Event and Device Deficiency Definitions .................................................................... 41 
Table 5: Reporting requirements of applicable events and device deficiencies. ...................................... 44 
Table 6: Study Contact Information.................................................................................................... 47 
Table 7: Investigator reports applicable to Europe, Middle East and Africa per ISO 14155 ..................... 55 
Table 8: Sponsor reports for Europe, Middle East and Africa ................................................................ 56 
 
 
 

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3. Glossary     
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASA 
American Society of Anesthesiologists 
ASADE 
Anticipated Serious Adverse Device Effect 
BMI 
Body Mass Index (kg/m2) 
CA 
Competent Authority 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
CNIL 
Commission Nationale de l’Informatique et des Libertés 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DoH 
Declaration of Helsinki 
EC 
Ethics Committee 
EU MDR 
European Medical Device Regulation 
FD 
Financial Disclosure 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act 
GCP 
Good Clinical Practice 
Hernia 
A clinically manifested bulge or a protrusion exacerbated by a 
Valsalva maneuver. 

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Term 
Definition 
IC 
Informed Consent 
ICH 
International Conference of Harmonization 
ICJME 
International Committee of Medical Journal Editors 
IFU 
Instructions For Use 
MedDRA 
Medical Dictionary for Regulatory Activities 
PMCF 
Post-Market Clinical Follow-up  
QoL 
Quality of Life 
RA 
Regulatory Authority 
QOL 
Quality of Life 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SSI 
Surgical Site Infection 
U(S)ADE 
Unanticipated (Serious) Adverse Device Effect 
VAS 
Visual Analog Scale - a psychometric response scale (0-10) which can 
be used in questionnaires to determine how much pain a subject is 
feeling.  

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4. Synopsis 
Title 
Poetry Study - PrOGrip™ Self-gripping Polyester Mesh Prospective 
Embedded REgisTRY for Abdominal Wall Suture Line Reinforcement in 
Patients Undergoing Midline Laparotomy to Prevent Incisional Hernia 
Clinical Study Type 
Post-Market Clinical Follow-up (PMCF) interventional study 
Product Name 
ProGrip™ Self-gripping Polyester Mesh 
Sponsor 
Medtronic, Covidien LP, MITG Surgical Innovations 
555 Long Wharf Drive  
New Haven, CT 06511 USA 
Local Sponsor 
Medtronic, Sofradim Production 
116 avenue du Formans 
01600 Trevoux, France 
External Organizations 
Club Hernie - CRO 8 allée 
 Mozart 
92190 Meudon, France 
Indication under 
investigation  
Reinforcement of abdominal suture line / Incisional hernia prevention 
Investigation Purpose 
To confirm the efficacy and safety of ProGrip™ Self-gripping Polyester 
Mesh for suture line reinforcement to reduce the incisional hernia 
incidence within 24 months after midline laparotomy. 
Product Status 
ProGrip™ Self-gripping Polyester Mesh is a CE-Mark cleared device. 
Primary Objective  
The primary objective of this investigation is to confirm the efficacy of 
ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of 
incisional hernia within 24 months post-operatively in subjects 
undergoing procedures with midline laparotomies. 
Secondary Objective  
The secondary objective of this investigation is to confirm the safety of 
ProGrip™ Self-gripping Polyester Mesh through the occurrence of 
adverse device effects or procedure related adverse events following 
the use of ProGrip™ Self- gripping Polyester Mesh in subjects 
undergoing procedures with midline laparotomies. 
Primary Endpoint  
Incisional hernia rate within 24 months of midline laparotomy assessed 
by CT-scan and physical examination including hernia clinical 
examination. 
Secondary Endpoints  
 
AE incidence reported by number, seriousness, and 
relationship to the procedure and device from the surgery to 
the 24-month visit 
 
Time to incisional hernia occurrence 
 
Post-operative pain at the site of surgery 

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 
Club Hernie Registry Quality of Life Questionnaire 
 
Patient satisfaction  
 
Surgeon satisfaction via questionnaire  
Study Design 
Prospective embedded registry study capturing outcomes after use of 
ProGrip™ Self-gripping Polyester mesh 
 
This study is a prospective, multicenter, PMCF embedded registry study 
evaluating the use of the ProGrip™ Self-gripping Polyester Mesh in 
subjects undergoing midline laparotomy in order to prevent incisional 
hernia using the embedded registry data of Club Hernie in France.  
 
The Club Hernie is a non-profit organization created in 2009, currently 
including 40 permanent French surgeon members, with the aim to 
improve the healthcare treatments in parietal surgery by an 
assessment of surgical practices, promoting research in abdominal wall 
surgery using an internet database open to surgeon members to 
monitor their own hernia practice and outcomes. 
 
This study utilizes the Club Hernie established registry database. This 
online database consists of systematic and consecutive data entry of 
all subjects treated for abdominal wall surgery with standard data 
capture of all preoperative, perioperative and post-operative data. 
 
Subjects who meet the eligibility criteria will be considered for study 
participation and will be evaluated at screening/baseline, procedure, 
Day 1, discharge, Day 8, and 1, 12, and 24 months post-surgery. The 
planned enrollment period is 22 months in up to 12 sites in France. For 
this study select Club Hernie permanent members, non-permanent and 
new members are considered for participation. 
 
The planned follow-up period is 24 months after the last subject 
enrolled 
Sample Size 
At least 135 subjects may be enrolled in up to 12 French study sites 
using the embedded registry data of Club Hernie. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
Subjects are eligible to be enrolled in the study only if they meet all 
of the following criteria: 
1. Subject has provided informed consent. 
2. Subject is ≥ 18 years of age at the time of consent. 

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3. Subject will be undergoing an elective midline laparotomy. 
4. Subject may have a combination of low- and high-risk factors 
but cannot exceed a total of 5 risk factors or have more than 
2 high-risk factors. Subject must have at least 2 low-risk 
factors if subject does not have any high-risk factors. High- 
and low-risk factors include: 
a. High-Risk Factors (maximum of 2): 
i. BMI ≥ 35 
ii. Prior open abdominal surgery 
iii. Daily active smoker or Chronic Obstructive 
Pulmonary disease (COPD) diagnosis 
iv. Current or recent (within 1 year) cancer 
diagnosis or chemotherapy treatment 
v. History of or current abdominal aorta 
aneurism or surgery for abdominal aorta 
aneurism 
b. Low-Risk Factors (minimum of 2, if no high-risk 
factors): 
i. 25 ≤ BMI < 35 
ii. Age > 45 
iii. Uncontrolled diabetes 
iv. Malnutrition as defined by 10% weight loss 
within the last 3 months 
v. Current immunosuppressive treatment 
vi. Undergoing colorectal surgery 
 
Exclusion Criteria 
Subjects will be excluded from enrollment in the study if they meet 
any of the following criteria: 
1. Subject is undergoing emergency surgery, i.e. lifesaving 
procedures performed where subject is in imminent danger 
of death. 
2. Subject for which the device is used outside the product IFU, 
including; 
a. Pregnant women: Women who are known or 
suspected to be pregnant, or who are planning to 
become pregnant during the study follow-up period  
b. Subject who has an infection within 30 days of 
enrollment or, at the time of the surgery, has any 
active, acute or chronic infection(s) that are 
uncontrolled and/or requiring treatment such as 
antibiotics 
c. Subject whose surgical site is contaminated or 

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dirty/infected intraoperatively, as assessed by the 
Investigator (Exclude Altemeier classification III-IV). 
3. Subject who had received a mesh in a previous ventral hernia 
repair or has a ventral hernia. 
4. Investigator determined that a planned future surgery would 
interfere with application of mesh reinforcement. 
5. Subject has participated in an investigational drug or device 
research study within 30 days of enrollment. 
6. Subject has a life expectancy of <2 years. 
7. Subject has an ASA Physical Status Classification System score 
>3. 
8. Subject has >5 total risk factors or >2 high-risk factors 
Study Procedures and 
Assessments 
Subjects will be evaluated at baseline/screening, during the procedure, 
at day 1, at discharge, day 8, 1 Month, 12 Months, and 24 Months post-
surgery. 
Assessments to be conducted/data collected include: 
Preoperative data (Day -30 to 0) 
 
Informed consent 
 
Eligibility assessment 
 
Demographic data (age, gender, ASA score, BMI, subject’s 
 
occupation) 
 
Relevant prior medical/surgical history (previous surgical 
 
procedure) 
 
Serum or urine pregnancy test, for female subjects (unless the 
patient is surgically sterile or postmenopausal for at least two 
years). 
Operative data (Day 0) 
 
Date of surgery 
 
Indication of the procedure 
 
Surgical technique for laparotomy closure (closure technique 
 
and type of suture) 
 
Mesh reference (TMP1509G, TMP1515G, TMP2015G, 
TMP3015G, TMP1008G, TMP2008G, TMP3008G, TMP4008G) 
and lot number 
 
Type of fixation 
 
Operative time (from incision to closure, skin to skin), 
 
Mesh positioning and time 
 
Peri-operative events including adverse device effects or 
procedure related adverse events 
 
Surgeon satisfaction (Mesh handling, mesh manipulability, 
ease of use) 
Post-operative course (Day 0) Follow up 
 
Post-operative pain assessment measured utilizing a 0-10 

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 
Visual Analog Scale (VAS) (Worst pain experienced over the 
last 24 hours). 
Post-operative course (Day 1) Follow up 
 
Pain assessment measured with VAS score 
 
Post-operative adverse events (including adverse device 
effects or procedure related adverse events: SSI, hematoma, 
seroma, etc.) Data will be recorded in the discharge data 
Discharge data 
 
Date of discharge 
 
Length of Hospital stay (number of nights in the institution 
after the surgery) 
 
Post-operative adverse events (including adverse device 
effects or procedure related adverse events: SSI, hematoma, 
seroma, etc.). 
Post-operative course (Day 8, +/- 2days) Follow up 
 
Pain assessment measured with VAS score, either during 
systematic clinical visit or by phone call when a subject is 
already discharged. 
1 month (Day 30, +/- 1week) Follow up 
 
Pain assessment measured with VAS score 
 
Physical exam including hernia clinical examination 
 
Post-operative adverse events (including adverse device 
effects or procedure related adverse events). 
 
Club Hernie Registry Quality of Life (QoL) Questionnaire 
12 months (-1/+4weeks) Follow up 
 
Physical exam including hernia clinical examination 
 
Abdominal CT-Scan 
 
Post-operative adverse events (including adverse device 
effects or procedure related adverse events) 
 
Club Hernie Registry QoL questionnaire and patient 
satisfaction 
 
Pain assessment measured with VAS score 
NOTE: 1 Month prior, all subject will be contacted by phone in order 
to complete a self-assessment questionnaire and to remind them of 
the 1-year follow-up visit. 
24 months (-1/+4weeks) Follow up 
 
Physical exam including hernia clinical examination 
 
Abdominal CT-Scan 
 
Post-operative adverse events (including adverse device 
effects or procedure related adverse events) 
 
Club Hernie Registry QoL questionnaire and patient 
satisfaction 
 
Pain assessment measured with VAS score 

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NOTE: 1 Month prior, all subjects will be contacted by phone in order 
to complete a self-assessment questionnaire and to remind them of 
the 2-year follow-up visit 
Safety Assessments 
The incidence of AEs related to device and/or procedure will be 
recorded from the surgery through the 24 months post-operative 
follow-up. The data will be analyzed in the Safety Analysis Set. 
 Statistics 
Sample size determination 
Sample size is determined based on primary performance endpoint 
assuming the superiority of ProGrip™ Self-gripping Polyester Mesh use 
to prevent incisional hernia vs no prevention of incisional hernia within 
2-years following a midline laparotomy procedure. 
The literature review showed an incisional hernia rate after midline 
laparotomies around 20%.  Using a power (1-β) of 80% and a 5% error 
type I (two-sided) and considering a hypothetic incisional hernia rate 
of 10% for subjects with ProGrip™ Self-gripping Polyester Mesh, versus 
a theoretical hypothetic incisional hernia rate of 20% for subjects 
without any prevention following a midline laparotomy procedure, N= 
108 evaluable subjects are required. 
Assuming an attrition rate of 20% at 2-years, N=135 subjects will need 
to be enrolled. 
 
Statistical method 
Primary endpoint 
Statistical analysis of primary endpoint will be comparative. Binomial 
one-way test will be used to compare the observed ProGrip™ Self 
gripping Polyester Mesh incisional hernia incidence rate to the 20% 
theoretical incidence rate (from no prevention population), using a 
two- sided alpha-level of 5%. 
Other endpoints will be analyzed using descriptive methods: 
 
Qualitative variables will be described by their absolute and 
relative (%) frequencies of each class or value, and by two 
tailed 95% confidence intervals. 
 
Quantitative variables will be described by their mean, 
standard deviation (SD), extreme values (minimum and 
maximum values), and number of missing data and by two 
tailed 95% confidence intervals. 
Performance analyses will be run on: 
 
Performance Analysis Set includes all enrolled subjects 
excluding subjects who became pregnant during the follow-

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up, or subjects who undergo unscheduled abdominal surgery 
during study follow-up, which may increase the risk and cause 
of incisional hernia occurrence*. 
 
*Subject follow-up data, starting from the event’s occurrence, will be 
excluded/remove from the performance analysis. 
 
Per Protocol Analysis Set (PPAS) is a subset of PAS excluding 
subjects with protocol violation and major protocol 
deviation(s) that may impact the primary endpoint 
assessment. More precisely, reason for exclusion may include 
but is not limited to: 
 
Patient wrongly included (i.e. patient was enrolled 
but does not meet all the eligibility criteria). 
 
Failure to obtain informed consent. 
 
Deviation resulting from device use outside the 
recommended use in the IFU. 
 
Patient who receives the incorrect device or device is 
misused. 
 
Safety analyses will be run on: 
 
Safety Analysis Set includes all enrolled subjects. 
 
Interim Analysis 
After half the enrolled subjects complete the 1-year follow-up 
timepoint, an interim analysis will be conducted for regulatory 
purposes. An additional interim analysis for regulatory needs may also 
be conducted as needed. 
5. Introduction  
5.1. Background  
Although laparoscopic minimally invasive surgeries have increased in frequency, midline laparotomies are 
still common in both elective and emergency cases. After midline laparotomy, the prevalence of incisional 
hernias ranges between 10% and 54% depending on if the procedure was elective or emergency (1-3). 
The presence of an incisional hernia can lead to complications such as bowel obstruction, incarceration, 
strangulation, and/or patient discomfort and pain (4). Repair of incisional hernias requires additional 
procedure adding additional risk to the patient and finical costs. As a result, prevention of incisional 
hernias has become a common goal and in recent years, multiple studies have shown decreased frequency 
of incisional hernias when using prophylactic polypropylene mesh after midline laparotomies. 

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To that end, based on the extensive long-term data attained during the development of multiple surgical 
meshes for use in a variety of soft tissue repairs, Medtronic has developed the ProGrip™ self-gripping 
polyester mesh. Composed of knitted monofilament polyester with polylactic acid monofilament 
resorbable pins ProGrip™ self-gripping polyester mesh is intended for use in reinforcement of soft tissue 
where weakness exists, in procedures involving the repair of inguinal and incisional hernias or abdominal 
suture line reinforcement. 
 
Medtronic has conducted a biocompatibility evaluation of ProGrip™ self-gripping polyester mesh, 
compliant with the standard EN ISO 10993‐1 (2009), which demonstrates the biological safety of the 
device. Pre-clinical animal testing of ProGrip™ self-gripping polyester mesh demonstrates that the mesh 
shows the same inflammatory reaction as Parietex™ mesh, similar gripping power to ProGrip™ self-
gripping polypropylene mesh and contributes to the fixation of the mesh to the surrounding tissues better 
than Parietex™ mesh. Along with this data, ProGrip™ Self Gripping Polyester has been available for use in 
inguinal and incisional hernia repair since 2008 and the available data support a positive risk/benefit ratio 
for the device. 
5.2. Purpose 
Medtronic is sponsoring the POETRY study, a multi-site, prospective registry-embedded, post-market 
clinical follow up interventional study.  The purpose of this study is to confirm the efficacy and safety of 
ProGrip™ Self-gripping Polyester Mesh for suture line reinforcement to reduce the incisional hernia 
incidence within 24 months in a minimum of 135 enrolled subjects undergoing procedures with midline 
laparotomies. 
6. Objectives and Endpoints 
6.1. Objectives 
6.1.1. 
Primary Objective 
The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester 
Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects 
undergoing procedure with midline laparotomies. 
6.1.2. 
Secondary Objective  
The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester 
Mesh through the occurrence of adverse device effects or procedure related adverse events following the 

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use of ProGrip™ Self-gripping Polyester Mesh in subjects undergoing procedures with midline 
laparotomies. 
6.2. Endpoints 
6.2.1. Primary Endpoint 
The primary endpoint is the incisional hernia incidence rate within 24 months of midline laparotomy 
assessed by CT-scan and physical examination including hernia clinical examination. CT scan is one of the 
medical imagery exams that are used to confirm the incisional hernia. A confirmation to the clinical 
assessment is essential in order to not miss any incisional hernia occurrence. CT scans are already part of 
the standard of care follow-up for the patient undergoing colorectal procedures. To avoid an additional 
imagery procedure for those patients and homogenize the type of imagery for the other patients, all the 
patients will have a CT scan. 
 
6.2.2. Secondary Endpoints 
The following secondary endpoints will be assessed; 
 
Adverse event (AE) incidence reported by number, seriousness, and relationship to the 
procedure and device from the surgery to the 24-month visit  
 
Time to incisional hernia occurrence 
 
Post-operative pain at the site of surgery 
 
Club Hernie Registry Quality of Life Questionnaire 
 
Patient satisfaction 
 
Surgeon satisfaction via questionnaire 
7. Study Design  
This study is a prospective, multicenter, PMCF embedded registry study evaluating the use of the 
ProGrip™ Self-gripping Polyester Mesh in subjects undergoing midline laparotomy in order to prevent 
incisional hernia using the embedded registry data of Club Hernie in France. ProGrip™ Self-gripping 
Polyester Mesh is a CE-Mark cleared device. 
The study is expected to be conducted at up to 12 study sites located in France and at least 135 subjects 
will be enrolled in the study. To ensure a widespread distribution of data and minimize study site bias in 
study results, the maximum number of subjects to be enrolled at a single study site is 25 subjects. 
 
The Club Hernie is a non-profit organization created in 2009, currently including 40 French surgeon 
permanent members, with the aim to improve the healthcare treatments in parietal surgery by an 

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assessment of surgical practices, promoting research in abdominal wall surgery using an internet database 
open to surgeon members to monitor their own hernia practice and outcomes. 
 
This study utilizes the Club Hernie established registry database. This online database consists of 
systematic and consecutive data entry of all patients treated for abdominal wall surgery with standard 
data captured of all preoperative, perioperative and post-operative data.  
 
Out of the Club Hernie patient population, patients who meet the eligibility criteria will be considered for 
study participation and will sign the informed consent form and will be evaluated at screening/baseline. 
After the informed consent has been signed and the mesh has been implanted, the subject is considered 
enrolled, and they will also be evaluated at procedure, Day 1, discharge, Day 8, and 1, 12, and 24 months 
post-surgery. Enrollment period planned is 22 months in up to 12 sites in France. For this study Club Hernie 
select permanent members, non-permanent and new members are considered for participation. Subjects 
that withdraw or are lost to follow-up will not be replaced. Full details of subject exit, withdrawal, or 
discontinuation can be found in Section 11.13. 
7.1. Duration 
The expected total study duration is approximately 52 months, representing 28 months enrollment and 
24 months of follow-up. Screening for subject eligibility may occur up to 30 days (inclusive) prior to the 
procedure and post-procedure subjects will be assessed at Day 1, discharge, Day 8, and 1, 12, and 24 
months post-surgery. At least 135 subjects will participate in the study for a maximum of approximately 
26 months. 
7.2. Rationale  
ProGrip™ Self-gripping Polyester Mesh is a CE-Mark cleared device for abdominal suture line 
reinforcement since January 2018. 
 
To confirm the efficacy and safety of ProGrip™ Self-gripping Polyester Mesh for suture line reinforcement 
to reduce the incisional hernia Medtronic is performing an embedded registry study. Following use of 
ProGrip™ Self-gripping Polyester Mesh, incisional hernia rate and adverse event rates will be followed for 
24 months. Currently there are no known factors (apart from those identified in the IFU) that may 
compromise study outcomes or the interpretation of results (e.g., baseline characteristics, the use of 
other study products, or subject-related factors such as age, gender or lifestyle). If any adverse device 
effect occurrences are identified they will be assessed, reported and documented in the Club Hernie 
Registry Database as well as in the AE report form. As a single arm safety study, no comparator device will 
be used.  

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7.3 Study Oversight  
The Steering Committee will consist of select Investigators participating in this study, Club Hernie 
leadership, as well as appropriate members of Medtronic Clinical and Medical Affairs. The role of the 
Steering Committee is to make recommendations on the design and conduct of the study, the analysis of 
data, and the communication of results in alignment with the Medtronic Publication and Authorship 
Policy. The Steering Committee will also review aggregate adverse event data on an as needed basis, as 
described in the Steering Committee Charter. 
8. Product Description 
ProGrip™ self-gripping polyester mesh is made of knitted monofilament polyester with polylactic acid 
monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation 
of the mesh to the surrounding tissue. The monofilament polylactic acid pins are bioresorbable and 
contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid 
pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into carbon dioxide (CO₂) 
and water (H₂O). The mesh is available in different sizes of rectangular sheet. 
 
 
TMP1509G: Rectangular 15 x 9 cm 
TMP1515G: Rectangular 15 x 15 cm 
TMP2015G: Rectangular 20 x 15 cm 
TMP3015G: Rectangular 30 x 15 cm 
TMP1008G: Rectangular 10 x 8 cm* 
TMP2008G: Rectangular 20 x 8 cm* 
TMP3008G: Rectangular 30 x 8 cm* 
TMP4008G: Rectangular 40 x 8 cm* 
Figure 1. ProGrip™ Self-Gripping Polyester Mesh (rectangular) and TMP Codes with sizes for this study 
*Added to the study 25 Sep 2020 
 
All materials that may be in contact with tissues and/or body fluids are presented in Table 1. 
Table 1: Materials in contact with tissues and/or body fluids 
ProGrip™ self-gripping polyester mesh 
components 
Materials 
Mesh 
Monofilament polyester 
Resorbable pins 
Polylactic acid monofilament 
 
This CE marked device will be used within intended use as described in the approved IFU for which CE 
mark has been obtained. 

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8.1. Manufacturer 
ProGrip™ Self-Gripping Polyester Mesh is manufactured by Sofradim Production, (wholly owned 
subsidiary of Medtronic plc.) in Trévoux, France. 
8.2. Packaging 
The device is intended for single use only and is provided in an ethylene oxide sterilized package which 
includes an expiration date and lot number. A single (1) mesh is contained in each box. 
8.3. Intended Population 
ProGrip™ self-gripping polyester mesh is intended for use in reinforcement of soft tissue where weakness 
exists, in procedures involving abdominal suture line reinforcement. A thorough assessment of each 
patient’s medical history and conditions shall be performed to determine the suitability for prophylactic 
mesh augmentation with ProGrip™ self-gripping polyester mesh in the prevention of incisional hernia. 
8.4. Product Use 
Full operating steps are described in the instructions for use (Appendix B, Section 19.2). Briefly, 
 
The device is designed to be implanted outside of the peritoneal cavity. 
 
This mesh can be used whole or cut to the required dimensions. 
 
In case of abdominal suture line reinforcement, the placement of the mesh should ensure 
necessary overlap of the weakness, according to the surgeon’s practice. 
 
Only a single mesh should be used per subject.  
Approximately 135 mesh devices (one per subject) of TMP1509G, TMP1515G, TMP2015G, TMP3015G, 
TMP1008G, TMP2008G, TMP3008G, or TMP4008G are expected to be used for the study. 
8.5. Product Training Requirements 
Each Investigator participating in the clinical study and the associated clinical study staff will receive 
training on ProGrip™ self-gripping polyester mesh, if necessary. Investigators and study staff will be 
trained on device characteristics, shelf life, storage requirements, device use, and warnings, precautions 
and contraindications. 
 
For investigators who do not know ProGrip™ self-gripping polyester mesh prior to enrolling subjects, they 
must certify their understanding of the operative technique and anticipated complications associated with 
the use of this device by completing at least (1) case using the device. 

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8.6. Product Receipt and Tracking 
ProGrip™ self-gripping polyester mesh will be provided to each site upon Sponsor collection and approval 
of all required regulatory documentation. The ProGrip™ self-gripping polyester mesh will be labeled “For 
MDT17048POETRY Clinical Investigation”. Device accountability logs and clinical material shipment/return 
forms will be provided to the site. It is the site’s responsibility to document the receipt (maintain material 
shipment/return forms), disposition of the product (per subject use, including amount used, amount 
remaining, etc.), transfer (if applicable) and return of all unopened study devices. 
8.7. Product Storage 
Once received at the study site, ProGrip™ self-gripping polyester mesh must be stored at room 
temperature in a secure (locked) location at the study site. Access should be limited to designated study 
staff only.  It is the responsibility of the investigator to correctly handle and store market released product. 
These products will be used according to their labeling. The investigator shall make sure that all 
investigational devices will be stored in such a manner as to be easily identifiable. If the investigational 
device cannot be identified, the device shall not be used.  
8.8. Product Return 
All unused or expired ProGrip™ self-gripping polyester mesh should be returned to Medtronic within 30 
days of the last subject enrolled at the site and it will be documented in the product accountability log 
and clinical material shipment/return form. If the products are explanted but not returned, a justification 
will be reported on the appropriate case report forms or disposition logs. To receive a Returned Product 
Mailer Kit, please contact your local Medtronic field personnel. Additionally, all products involved in a 
device deficiency and those removed from subjects should be returned to Medtronic as soon as 
reasonably possible.  
8.9. Product Accountability  
All products used in this study will be market released in the geographies they are used. Device 
Traceability may be required per local laws and regulations. If there are additional local requirements 
related to the ProGrip™ self-gripping polyester mesh beyond what is collected by Medtronic on the CRF, 
this is the Investigator’s responsibility and should be recorded in the subject’s medical records, but will 
not be collected by Medtronic (e.g., national registration card number, identification code linked to names 
and contact information, log of all subjects enrolled in the  study, lot or batch number).  
Medtronic will perform periodic reconciliation of the investigational product to ensure traceability. 

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9. Study Site Requirements 
9.1 Investigator / Investigation Study Site Selection 
All investigators managing the subject’s hernia must be qualified practitioners.  All implanting physicians 
must be experienced and/or trained in the handling of ProGrip™ self-gripping polyester mesh. 
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects involved 
in the clinical investigation. 
The principal investigator shall: 
 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
 
Be experienced in the field of application and training in the use of ProGrip™ self-gripping 
polyester mesh 
 
Disclose potential conflicts of interest, that interfere with the conduct of the clinical investigation 
or interpretation of results 
 
Has the ability to comply with the applicable EC and regulatory requirements 
 
Is not disbarred, disqualified, or working under sanctions in applicable regions 
 
Be registered at the CNOM 
 
Be able to demonstrate that the proposed investigational study site: 
 
Has adequate time and resources to conduct the study throughout the duration of the 
study 
 
Has access to the required number of eligible subjects needed within the recruitment 
period 
 
Has one or more qualified investigators, a qualified investigational study site team and 
adequate facilities for the foreseen duration of the clinical investigation 
 
Has not had early termination and/or known instances of non-compliance from other 
clinical studies 
 
Adequate study device storage location(s) and processes 
 
Acceptable audit or inspection history 
 
Acceptable anticipated study startup timeline 
 
Lack of potential competition for the same subject population from other ongoing studies 
Study site personnel training will be completed and documented prior to participation in this study. 
9.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel on 
the clinical investigation plan, on relevant standards and regulations, informed consent, and on data 

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collection and reporting tools. If new members join the study site team, they will receive training on the 
applicable study requirements relevant to their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following:  
 
EC approval (and voting list, as required by local law) of the current version of the CIP and IC.  
 
RA approval or notification (as required per local law)  
 
Fully executed CTA  
 
CV of investigators and key members of the investigation study site team (as required). The 
signature on the CV must be dated within 3 years prior to the date of activation of the study site.   
 
Documentation of delegated tasks 
 
Documentation of study training  
 
Additional requirements imposed by local regulations, the EC and RA shall be followed, if 
appropriate.  
 
In addition, all participating study site staff must be trained on the current version of the CIP as well as on 
the applicable study requirements depending on their role and must be delegated by the principal 
investigator to perform study related activities.   
Medtronic will provide each study site with documentation of study site/investigator readiness; this letter 
must be received prior to performing study related activities.  
9.3 Role of the Sponsor Representatives 
Sponsor representatives may provide support at the study site as required for the study under supervision 
of the Principal Investigator, including: 
 
Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities 
 
Technical support under the supervision of a study investigator, but no data entry, shall be 
performed by Medtronic personnel or their representatives at study sites 
 
Monitoring and auditing activities  
 
In addition, for this study, sponsor representatives may be authorized by the Principal Investigator to 
perform the following significant trial related duties:  
 
Provide technical support to study investigators performing the study implant procedure 

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10. Selection of Subjects 
10.1. Study Population 
At least 135 subjects undergoing midline laparotomy may be enrolled in up to 12 sites in France using the 
embedded registry data of Club Hernie. Each site will be allowed to enroll between 1 and 25 subjects. To 
reduce bias, enrollment will not exceed 25 subjects per site. No randomization, or blinding will take place 
during the study. 
10.2. Subject Enrollment 
A subject is considered enrolled in the study when it is confirmed they meet all pre-operative inclusion 
and no exclusion criteria, the ICF is signed and they have been implanted with the device. A subject must 
be followed for the full 24 months if the procedure was begun or completed with the study device. No 
study procedures, or data collection will be performed until informed consent form has been completed. 
10.3. Inclusion Criteria 
Subjects are eligible to be enrolled in the study only if they meet all of the following criteria: 
1. Subject has provided informed consent. 
2. Subject is ≥ 18 years of age at the time of consent. 
3. Subject will be undergoing an elective midline laparotomy. 
4. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk 
factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if 
subject does not have any high-risk factors. High- and low-risk factors include:  
a. High-Risk Factors (maximum of 2): 
i. BMI ≥ 35 
ii. Prior open abdominal surgery 
iii. Daily active smoker or Chronic Obstructive Pulmonary Disease (COPD) diagnosis 
iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment 
v. History of or current abdominal aorta aneurism or surgery for abdominal aorta 
aneurism 
b. Low-Risk Factors (minimum of 2, if no high-risk factors): 
i. 25 ≤ BMI < 35 
ii. Age > 45 
iii. Uncontrolled diabetes 
iv. Malnutrition as defined by 10% weight loss within the last 3 months 
v. Current immunosuppressive treatment 
vi. Colorectal surgery 

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10.4. Exclusion Criteria 
Subjects will be excluded from enrollment in the study if they meet any of the following criteria: 
1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is 
in imminent danger of death. 
2. Subject for which the device is used outside the product IFU, including; 
a. Pregnant women: Women who are known or suspected to be pregnant, or who are 
planning to become pregnant during the study follow-up period  
b. Subject who has an infection within 30 days of enrollment or, or at the time of the 
surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or 
requiring treatment such as antibiotics 
c. Subject whose surgical site is contaminated or dirty/infected intraoperativly, as assessed 
by the Investigator (Exclude Altemeier classification III-IV) 
3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia. 
4. Investigator determined that a planned future surgery would interfere with application of mesh 
reinforcement. 
5. Subject has participated in an investigational drug or device research study within 30 days of 
enrollment. 
6. Subject has a life expectancy of <2 years. 
7. Subject has an ASA Physical Status Classification System score >3.  
8. Subject has > 5 total risk factors or > 2 high-risk factors. 
 
 
 

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11. Study Procedures  
11.1 Schedule of Events  
Subjects will be evaluated at screening/baseline, procedure, Day 1, discharge, Day 8, and 1, 12, and 24 months post-surgery. Refer to Section 
11.2 for procedure/assessments collected at each visit. 
11.2 Data Collection 
Table 2: Schedule of Events 
Procedure/Assessment 
Screening 
(Day -30 to 
0) 
Operative 
(Day 0) 
Post-operative 
course (Day 0) 
Follow up 
Post-operative 
course (Day 1) 
Follow up 
Discharge 
Assessment 
Post-operative 
course (Day 8, 
+/-2days) 
Follow Up 
1 Month 
(Day 30, 
+/-1week) 
Follow-up 
12 Months 
(-1/+4 
weeks) 
Follow-up 
24 Months 
(-1/+4 
weeks) 
Follow-up 
Can be combined 
Eligibility criteria 
X1 
X1 
 
 
 
 
 
 
 
Informed consent 
X2 
 
 
 
 
 
 
 
 
Pregnancy Test 
X3 
 
 
 
 
 
 
 
 
Subject demographics 
X 
 
 
 
 
 
 
 
 
Relevant prior 
medical/surgical history 
X 
 
 
 
 
 
 
 
 
Surgical Data 
Date of surgery 
 
X 
 
 
 
 
 
 
 
Procedure indication 
 
X 
 
 
 
 
 
 
 
Surgical technique for 
laparotomy closure 
 
X 
 
 
 
 
 
 
 
Mesh reference and lot 
number 
 
X 
 
 
 
 
 
 
 
Type of fixation 
 
X 
 
 
 
 
 
 
 
Operative time 
 
X 
 
 
 
 
 
 
 

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Procedure/Assessment 
Screening 
(Day -30 to 
0) 
Operative 
(Day 0) 
Post-operative 
course (Day 0) 
Follow up 
Post-operative 
course (Day 1) 
Follow up 
Discharge 
Assessment 
Post-operative 
course (Day 8, 
+/-2days) 
Follow Up 
1 Month 
(Day 30, 
+/-1week) 
Follow-up 
12 Months 
(-1/+4 
weeks) 
Follow-up 
24 Months 
(-1/+4 
weeks) 
Follow-up 
Can be combined 
Mesh positioning and time 
 
X 
 
 
 
 
 
 
 
Peri-operative events 
(including adverse device 
effects or procedure related 
adverse events) 
 
X 
 
 
 
 
 
 
 
Surgeon satisfaction 
 
X 
 
 
 
 
 
 
 
Post-operative data 
AE, SAE, & DD Data 
 
 
X 
X 
X 
X 
X 
X 
X 
VAS pain assessment4 
 
 
X 
X 
 
X 
X 
X 
X 
Post‐operative adverse 
events 
 
 
 
X 
X 
 
X 
X 
X 
Date of discharge 
 
 
 
 
X 
 
 
 
 
Length of Hospital stay 
 
 
 
 
X 
 
 
 
 
Physical exam including 
hernia clinical examination4 
 
 
 
 
 
 
X 
X 
X 
Abdominal CT Scan4 
 
 
 
 
 
 
 
X 
X 
Quality of Life 
Questionnaire4 
 
 
 
 
 
 
X 
X 
X 
Patient Satisfaction4 
 
 
 
 
 
 
 
X 
X 
1-month prior phone call 
including self-assessments4 
 
 
 
 
 
 
 
X 
X 
Study Exit 
 
 
 
 
 
 
 
 
X 
1. 
If Screening and Surgery occur on different days, these procedures should occur during Screening and be reconfirmed on the day of surgery. 
2. 
No study procedures will be performed until informed consent form has been completed. Subject should be re-consented if date of original consent is greater than 30 days. 
3. 
Serum or urine pregnancy test for female subjects (unless the patient is surgically sterile or postmenopausal for at least two years). 
4. 
These procedures/assessments may not be considered standard of care based upon local standards or index procedure type  

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11.3 Scheduled Follow-up Visit Windows 
Should a subject miss a visit or the visit fall outside the pre-specified window, a study deviation must be 
reported, and the original follow-up schedule maintained for subsequent visits.  
Data analyses include follow-up visits, regardless of whether the visit occurs within the window.   
Therefore, a late visit is preferred over a missed visit but must be accompanied by a deviation report. 
Follow-up visit windows are listed in Table 3 and are based on days post-operative. 
Table 3: Data collection and study procedure requirements at subject visits 
Study Follow-up 
Visit 
Window 
(Calculated days post-operative) 
Window Start 
(post-implant) 
Target 
(post-implant) 
Window End 
(post-implant) 
Follow-up 1 
Day 6 
Day 8 
Day 10 
Follow-up 2 
Day 23 
Day 30 
Day 37 
Follow-up 3 
11 Months, 3 Weeks 
12 Months 
13 Months 
Follow-up 4 
23 Months, 3 Weeks 
24 Months 
25 Months 
 
11.4 Subject Screening  
A screening visit will be used to confirm pre-operative eligibility and consent subjects. Subjects will be 
consented prior any procedures specific to the study are undertaken. The purpose and all aspects of the 
study will be explained to the subject. Subjects who agree to study participation must sign and personally 
date the sponsor and an EC-approved informed consent form prior to participating in any study activities. 
 
Once the consent process has been completed, pre-operative eligibility has been confirmed, the following 
data will be collected: 
 
Demographic data (e.g. age, gender, ASA score, BMI, subject’s occupation) 
 
Relevant prior medical/surgical history (e.g. previous surgical procedure) 
 
Serum or urine pregnancy test, for female subjects (unless the patient is surgically sterile or 
postmenopausal for at least two years). 
The screening visit will be performed within 30 days up to the day of the scheduled procedure and may 
be combined with the surgery procedure visit. If screening and/or ICF signature occur more than 30 days 
before the procedure the subject is to be rescreened and reconsented. 

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11.5 Subject Consent 
Informed consent is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular study after information has been given and explained to the 
subject on all aspects of the study that are relevant to the subject’s decision to participate. This process 
includes obtaining an IC form that has been approved by the study site’s EC and signed and dated by the 
subject. A subject may only consent after information has been given and explained to the subject on all 
aspects of the clinical investigation that are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, the IC site must be approved by the EC.  The document(s) must be controlled 
(i.e. versioned and/or dated) to ensure it is clear which version(s) were approved by the EC.  Any 
adaptation of the sample IC must be reviewed and approved by Medtronic and the EC reviewing the 
application prior to enrolling subjects.  
The investigator must notify the subject of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the subject, 
as this could impact a subject’s willingness to participate in the study. If relevant, consent may be 
requested from subjects to confirm their continued participation. 
Prior to initiation of any study-specific procedures, IC must be obtained from the subject. Likewise, privacy 
or health information protection regulation may require subjects to sign additional forms to authorize 
study sites to submit subject information to the study sponsor. The IC process must be conducted by the 
principal investigator or an authorized designee, and the IC Form and must be given to the subject in a 
language he/she is able to read and understand. The process of IC must be conducted without using 
coercion or undue improper influence on or inducement of the subject to participate by the investigator 
or other study site personnel. The IC process shall not waive or appear to waive subject’s legal right. The 
language used shall be as non-technical as possible and must be understandable to the subject.  
The subject must have ample time and opportunity to read and understand the IC form, to inquire about 
details of the study, and to decide whether or not to participate in the study. All questions about the study 
should be answered to the satisfaction of the subject. 
When the subject decides to participate in the study, the IC must be signed and personally dated by the 
subject and investigator or authorized designee, as required by the IC, and ensured by the principal 
investigator or his/her authorized designee.  
If the IC is obtained the same day the subject begins participating in study-related procedures, it must be 
documented in the subject’s case history that consent was obtained prior to participation in any study-
related procedures. It is best practice for the IC process to be documented in the subject’s case history, 
regardless of circumstance. The date the subject signed the IC and Data Protection Authorization, as 
required by law, must be documented in the subject’s medical records. 

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The original of the signed IC must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  
The IC must be available for monitoring and auditing. Any Medtronic Field personnel who support the 
study procedure must be able to review the subject’s signed and dated IC and verify its completeness 
prior to proceeding with the implant. In the event the Medtronic Field personnel identify IC as being 
incomplete, the study procedure will not be allowed to occur until the consent of the subject can be 
adequately and appropriately obtained.  
A log of all subjects enrolled in the study should be maintained. Enrollment can be a stand-alone visit or 
can occur on the same day as the screening visit or operative day. Once consent is obtained, report 
adverse events/deaths, study deviations and subject exits as they occur. 
11.6 Operative Day (D0) 
The following information is required to be collected on the operative day: 
 
Date of surgery 
 
Indication of the procedure 
 
Surgical technique for laparotomy closure (closure technique and type of suture) 
 
Mesh reference (TMP1509G, TMP1515G, TMP2015G, TMP3015G, TMP1008G, TMP2008G, 
TMP3008G, TMP4008G) and lot number 
 
Type of fixation 
 
Operative time (from incision to closure, skin to skin), 
 
Mesh positioning and time 
 
Peri-operative events including adverse device effects or procedure related adverse events 
 
Surgeon satisfaction (Club Hernie questionnaire regarding surgeon satisfaction of mesh handling, 
mesh manipulability, ease of use) 
11.7 Scheduled Follow-up Visits 
11.7.1 Post-operative course (D0) Follow up 
The following information is required to be collected post-operatively on the operative day: 
 
Post-operative pain assessment measured utilizing a 0-10 Visual Analog Scale (VAS) (Worst pain 
experienced over the last 24 hours). 
11.7.2 Post-operative course (D1) Follow up 
The following information is required to be collected during post-operative day 1: 
 
Pain assessment measured with VAS score 
 
Post-operative adverse events (including adverse device effects or procedure related adverse 
events: SSI, hematoma, seroma, etc.). Data will be recorded in the discharge data.  

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11.7.3 Discharge Data 
The following information is required to be collected during discharge: 
 
Date of discharge 
 
Length of Hospital stay (number of nights in the institution after the surgery) 
 
Post-operative adverse events (including adverse device effects or procedure related adverse 
events: SSI, hematoma, seroma, etc.) 
11.7.4 Post-operative course, Day 8, (-/+2days) Follow up 
The following information is required to be collected during the Day 8 post-operative follow up (-/+ 2 
days): 
 
Pain assessment measured with VAS score, either during systematic clinical visit or by phone 
call when a subject is already discharged. 
11.7.5 Post-operative course, Day 30, (-/+1 week) Follow up  
The following information is required to be collected during the Day 30 post-operative follow up (-/+ 1 
week): 
 
Pain assessment measured with VAS score 
 
Physical exam including hernia clinical examination 
 
Post-operative adverse events (including adverse device effects or procedure related adverse 
events). 
 
Club Hernie Registry Quality of Life (QoL) Questionnaire 
11.7.6 Post-operative course, 12 Months, (-1/+4 week) Follow up 
The following information is required to be collected during the 12 Months post-operative follow up (-
1/+4 weeks): 
 
Physical exam including hernia clinical examination 
 
Abdominal CT-Scan 
 
Post-operative adverse events (including adverse device effects or procedure related adverse 
events) 
 
Club Hernie Registry Quality of Life (QoL) Questionnaire and patient satisfaction  
 
Pain assessment measured with VAS score 
NOTE: 1 Month prior, all subjects will be contacted by phone in order to complete a self-assessment 
questionnaire and to remind them of the 1-year follow-up visit. 
11.7.7 Post-operative course, 24 Months, (-1/+4 week) Follow up  
The following information is required to be collected during the 24 Months post-operative follow up (-
1/+4 weeks): 
 
Physical exam including hernia clinical examination 

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 
Abdominal CT-Scan 
 
Post-operative adverse events (including adverse device effects or procedure related adverse 
events) 
 
Club Hernie Registry Quality of Life (QoL) Questionnaire and patient satisfaction  
 
Pain assessment measured with VAS score 
NOTE: 1 Month prior, all subjects will be contacted by phone in order to complete a self-assessment 
questionnaire and to remind them of the 2-year follow-up visit. 
11.7.8 End of Study  
After the 24-month follow-up no additional study related medical care will be provided, and subjects will 
receive the standard of care as determined appropriate by their physician.  
If the ProGrip™ Self- gripping polyester mesh is removed from the subject, they will be exited from the 
study 30 days after mesh removal.  
11.8 Subject Questionnaires 
During this study the Visual Analog Scale (VAS) will be used to measure subject pain. VAS is a psychometric 
response scale, first used by Hayes and Patterson in 1921 (1, 2) and currently referenced in more than 950 
published manuscripts. Scores are based on self-reported measures of symptoms that are recorded with 
a single handwritten mark placed at one point along the length of a 10-cm line that represents a 
continuum between the two ends of the scale, “no pain” on the left end (0 cm) of the scale and the “worst 
pain” on the right end of the scale (10 cm), which can be used in questionnaires to determine how much 
pain a subject is feeling.   
The Club Hernie Quality of Life and Patient Satisfaction Survey will be used to determine how satisfied a 
subject is with the mesh placement and what impact it has had on their quality of life. Along with the 
Surgeon Satisfaction Questionnaire, the Club Hernie Quality of Life and Patient Satisfaction Surveys used 
in this study were developed by Club Hernie and have been in use in their database since 1999. To date, 
these questionnaires have been published in numerous manuscripts (3-9), including a recent Medtronic 
sponsored study (10).   
11.9 Assessment of Efficacy 
Incisional hernia rate within 24 months of midline laparotomy as assessed by a CT-scan and a physical 
examination including a hernia clinical examination will be recorded in the Club Hernie Registry Database 
and used to assess the efficacy of the ProGrip™ Self- gripping polyester mesh. 

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11.10 Assessment of Safety 
The incidence of AEs related to device and/or procedure will be recorded starting at the time of informed 
consent signature through the 24 months post-operative follow-up. The data will be analyzed in the Safety 
Analysis Set. See Section 13 for further information on the collection of AEs and safety information.  
11.11 Recording Data 
This study will utilize the Club Hernie electronic database. All data requested on the Club Hernie Registry 
Database are required. Study visits or measurements not collected and/or recorded will be considered 
deviations unless otherwise specified. The Principal Investigator or authorized designee(s) must ensure 
the accuracy and completeness of the recorded data and then provide his/her electronic signature on the 
Club Hernie Registry Database (CNIL – Commission Nationale de l’Informatique et des Libertés – approved 
database). Each Principal Investigator or authorized designee(s) will be trained on the use of the Club 
Hernie database. Club Hernie does not have the capability to maintain an audit trail, data trail and edit 
trail; this is a deviation from ISO 14155:2020. All data (new, updated, previously entered) will be reviewed 
by sponsor with each Club Hernie database extraction.  Data accuracy will be assessed by source data 
verification during monitoring visits.  Prior to study closure each Principle Investigator will approve their 
final set of study data.  
 
Data entered must be traceable to source documents. Source documentation is defined as the first time 
data appear, and may include original documents, data, and records (e.g., hospital records, clinical and 
office charts, procedure reports, laboratory notes, memoranda or evaluation checklists, pharmacy 
dispensing records, copies or transcriptions certified after verification as being accurate copies, 
microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, device data and 
records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the  
study). 
 
In general, CRFs may not serve as source documents. The data reported on the CRFs and into Club Hernie 
shall be derived from and consistent with source documents, and any discrepancies shall be explained in 
writing by the site staff.  If data elements are not documented in the medical record, but are required for 
CRFs or Club Hernie an exception may be made (e.g., the completion of QoL Questionnaires, clinical scales, 
Inclusion CFRs, Study Exit CFRs, Protocol Deficiency CRFs, Device Deficiency CRFs, and Adverse Event 
CRFs). Source documentation for data elements not routinely captured in medical records may vary from 
study site to study site; the study site may use source document worksheets if identified as source 
documents. 
 
The investigator must ensure the availability of source documents from which the information on the CRFs 
or Club Hernie entry was derived. The type and location of source documents should be documented. 
Where printouts of electronic medical records, are provided as source documents, or where copies of 

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source documents are retained as source documents, those should be certified. Certification must contain 
(1) the signature of the individual making the copy, (2) the date the copy was made and (3) a statement 
attesting to the accuracy and completeness of the copy. 
11.12 Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the CIP or the CTA. 
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. The investigator is not allowed to deviate from the CIP, except 
under emergency circumstances to protect the rights, safety and well-being of human subjects. Prior 
approval is not required when a deviation is necessary to protect the safety, rights or well-being of a 
subject in an emergency or in unforeseen situations beyond the investigator’s control (e.g. subject failure 
to attend scheduled follow-up visits, inadvertent loss of data due to computer malfunction, inability to 
perform required procedures due to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis). However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported on the CRF regardless of whether medically justifiable, pre-
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
Multiple deviations of the same type at the same visit may be reported on one case report form. 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the EC as well as 
Medtronic within five (5) working days.  Reporting of all other study deviations should comply with EC 
policies and/or local laws and must be reported to Medtronic as soon as possible upon the study site 
becoming aware of the deviation. Reporting of deviations must comply with EC policies, local laws, and/or 
RA requirements.  
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation 
of a corrective or preventative action plan with the investigator and study site, and in some cases, may 
necessitate suspending enrollment until the problem is resolved or ultimately terminating the 
investigator's participation in the study. Medtronic will provide study site-specific reports to investigators 
summarizing information on deviations that occurred at the investigational study site on a periodic basis.  
Examples of study deviations include but are not limited to: 

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 
Failure to obtain proper IC 
 
Failure to collect required study data (e.g. required abdominal CT scan) 
 
Required study data collected outside of visit window 
 
Inclusion/exclusion criteria not met 
11.13 Subject Exit, Withdrawal or Discontinuation  
11.13.1 Study Exit 
A study exit CRF is required for all subjects. Prior to exiting a subject from the study, it is recommended 
to follow the subject until all ongoing system and/or procedure related AEs are resolved or unresolved 
with no further actions planned.  Following exit, subjects will continue to receive standard medical care. 
Upon exiting from the study, no further study data will be collected or study visits will occur for the 
subject. All data available through the time of the subject’s exit will be used for analysis.  
Subjects are urged to remain in the study as long as possible but may be exited from the study for any of 
the following situations: 
 
Study completed 
 
Subject lost to follow-up 
 
Subject death  
 
Subject chooses to withdraw (e.g., consent withdrawal)  
 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion criteria 
not met, failure of subject to maintain adequate study compliance) 
 
Mesh removal 
11.13.2 Screen Failure 
Subjects who provide study consent, but then are determined to be ineligible will be considered a screen 
failure and will not require additional study follow-up visits. The reason for the screening failure will be 
clearly recorded in the applicable POETRY Study Exit Form. 
11.13.3 Discontinuation 
Subjects who provide study consent, and are deemed eligible, but do not undergo the procedure with the 
study device will be considered “discontinued” and will be followed until discharge (no additional follow-
up visits will be required). The reason for discontinuation will be clearly recorded in the applicable POETRY 
Study Exit Form and Club Hernie Registry Database. 
11.13.4 Withdrawal 
The reason for study exit will be documented on the POETRY Study Exit form and Club Hernie Registry 
Database. A subject can withdraw from the study at any time. In the event the subject withdraws consent 
during the study, the date and reason for withdrawal (if known) will be documented. If the study 
Investigator voluntarily removes a subject from further study participation, supporting documentation 

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must be in place for the rationale and date of removal. Follow up of subjects withdrawn will be determined 
by investigator. Withdrawn subjects will not be replaced. 
11.13.5 Lost to Follow-Up 
Attempts to reach the subject will be performed by the site after each missed follow-up visit.  For each 
visit, the following should be performed; 
 
 Three (3) phone calls should be made to the subject at various times and least a day apart. Each 
attempt should be clearly documented in the source documents and the response or lack thereof 
should be captured.   
 
If there is no response to the phone calls, then an official, certified letter should be written to 
the subject. A copy of the letter and return or delivery receipts should be retained in the subject’s 
source document. 
The subject will not be considered lost to follow-up until the end of the study. Four (4) failed documented 
attempts of meticulous postal reminders and phone calls for each visit will be used to minimize the non-
response bias. Lost to Follow-up subjects will not be replaced.  
11.13.6  Mesh Removal 
In the case that the study mesh is removed from the subject the subject will be exited from the study 30 
day after mesh removal.  The reason for study exit will be documented on the POETRY Study Exit form 
and the mesh shall be returned to the sponsor. 
11.13.7 Study Completed 
At the completion of the 24-month follow-up visit, subjects will be exited from the study. The 24-month 
follow-up visit and exit visit should be combined, and both a 24-month follow-up CRF and a Study Exit CRF 
need to be completed.  
12. Risks and Benefits 
12.1. Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance. For 
studies following ISO 14155, the risk analysis process for the ProGrip™ self-gripping polyester mesh is 
being performed in accordance with ISO 14971, and will ensure that the level of risk is acceptable prior to 
starting the study. The residual risks have been classified as acceptable in the worst cases.  
 
Possible additional risks for participating in this study include the following (although others are possible): 
hematoma, seroma, adhesion, infection, fistula, chronic pain, inflammation, and recurrence, allergic 

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reaction to the components of the product and urinary retention (which may occur with the use of 
anesthetics). Details can be found in the device IFUs (Section 19.2).   
For subjects that are operated for an oncologic colorectal procedure, the abdominal CT-Scan is part of 
standard of care. For other procedures, as a result of participation in this study, subjects may be exposed 
to radiation from x-ray procedures. In addition to the routine procedures, the x-ray exams used for this 
study include a CT scan evaluation of the abdominal cavity. These x-ray exams deliver up to a total 
radiation dose of approximately 8 mSv each, and subjects will undergo 1 CT scans at the 1 and 2 year post-
operative visits. A milliSievert (mSv) is a unit of radiation dose. For comparison, the average person in 
France receives 2.9mSv each year from natural sources of radiation. A slight increase in cancer risk may 
exist for people exposed to radiation. 
Following the fluoroscopic procedure, as with any X-ray exposure in everyday life, the skin area exposed 
to those x-rays could react to produce an effect similar to a sun burn. A skin reaction, if it occurs at all, 
could show up from a few hours to a few weeks after the procedure, and usually goes away on its own. If 
a skin reaction is found the subject should promptly report this to the study physician. 
The mesh will not stretch to accommodate growth so it may be inappropriate to have a mesh implanted 
if the subject is planning a future pregnancy. A pregnancy after a laparotomy is a risk factor for developing 
an incisional hernia. 
There may be additional risks related to this study that are not yet known.  
12.2. Risk Minimization 
The potential risks associated with the ProGrip™ self-gripping polyester mesh were identified and have 
been successfully mitigated. Any potential risks associated with this study are further minimized by 
selecting qualified investigators and training study personnel on the CIP. Additionally, the study is 
performed per IFU indications and is on label use for the product.   
In addition, investigators will be actively involved in the implantation and follow-up of the subjects 
implanted with ProGrip™ self-gripping polyester mesh.  
Risks will be minimized by careful assessment of each subject prior to, during, and after implant of the 
ProGrip™ self-gripping polyester mesh. Prior to implant, it is recommended subjects undergo a complete 
physical evaluation. 
Medtronic has further minimized the possibility of risks by performing required laboratory and pre-
clinical testing prior to the POETRY study, implementing quality control measures into production 
processes, providing guidelines for subject selection and evaluation, and providing adequate instructions 
and labeling.  

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12.3. Potential Benefits 
The information obtained from this study will be used to confirm the safety and efficacy of ProGrip™ self-
gripping polyester mesh in abdominal suture line reinforcement. This information may lead to findings 
that could result in a reduction of adverse events for future subjects. The use of a preventative mesh could 
reduce the 10-50% rate of incisional hernias that occur after midline laparotomy and decrease 
complications associated with new surgery and incisional hernia repair. Additionally, information 
collected from this study may assist in the design of new product(s)/therapy(ies) and/or IFU. 
12.4. Risk-Benefit Rationale 
In use since 2008 for repair of inguinal and incisional hernia repair, numerous clinical trials have 
demonstrated the safety and effectiveness of ProGrip™ self-gripping polyester mesh (5-8). Including more 
than 2,400 patients in more than 20 clinical studies, ProGrip™ self-gripping polyester mesh demonstrates 
both a low global complication rate as well as a low device related complication rate (Publication 
summaries and data can be found in the ProGrip™ self-gripping polyester mesh Clinical Evaluation Report).  
Overall, a positive risk/benefit ratio has been demonstrated with ProGrip™ self-gripping polyester mesh 
as evidenced by these clinical studies, preclinical and biocompatibility testing. ProGrip™ self-gripping 
polyester mesh is a CE-Mark cleared device. Consequently, ProGrip™ self-gripping polyester mesh 
presents a favorable risk/benefit ratio to the subject. The instructions for use in addition to surgeon 
training, will instruct surgeons on proper use of the device to mitigate risk. There are currently no known 
interactions between ProGrip™ self-gripping polyester mesh and concurrent medical interventions.  
13. Adverse Events and Device Deficiencies 
Adverse event (AE) definitions used in this study are based on ISO 14155:2020 (Clinical Investigation of 
Medical Devices for Human Subjects -- Good Clinical Practice). 
13.1. Adverse Events 
AE definitions are provided in Section 13.4 (Table 4). During this study, only device and procedure related 
AEs, SAEs, DDs, and DDs with SADE potential will be collected throughout the study duration, starting at 
the time of signing the IC (this is a deviation from ISO 14155:2020). 
Reporting of these events to Medtronic will occur on a paper AE Form. Each event must be reported 
separately. Documented pre-existing conditions are not considered AEs unless the nature or severity of 
the condition has worsened.  
Anticipated Adverse Events following surgical procedures (primarily associated with anesthesia, listed in 
Table 4, need not be reported unless the adverse event worsens or is present outside the stated 
timeframe post-implant.  

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For AEs that require immediate reporting, initial reporting may be done by phone, fax, email or on the 
CRF completing as much information as possible. The completed AE CRF must be submitted to Medtronic 
as soon as possible.   
Any medication/treatment associated with the treatment of an AE must be reported.  
Subject deaths are also required to be reported. Refer to Section 13.8 for Subject Death collection and 
reporting requirements. 
13.2. Device Deficiency 
The device deficiency (DD) definition is provided in Section 13.4 (Table 4). DD and DD with SADE potential 
information will be collected throughout the study and reported to Medtronic. Note that a DD that results 
in an AE to the subject should be captured as an AE only. 
DD that did not lead to an AE but could have led to a SADE (i.e., if suitable action had not been taken, if 
intervention had not been made, or if the circumstances had been less fortunate) require immediate 
reporting.  
13.3 Processing Updates and Resolution 
For any changes in status of a previously reported adverse event or DD (i.e. change in actions taken, 
change in outcome, change in relatedness), information needs to be updated on, or added to a new AE or 
DD paper form. All AEs must be followed until the AE has been resolved, is unresolved with no further 
actions planned, the subject dies or exits the study, or until study closure, whichever occurs first.  
In the event that a subject is exited from the study prior to study completion, all efforts should be made 
to continue following the subject until all unresolved system or procedure related AEs, as classified by the 
investigator, are resolved, unresolved with no further actions planned, or 30 days, whichever occurs first.  
At the time of study exit, all collected adverse events that are unresolved must be reviewed and an update 
must be reported.  
13.4 Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study. This might be the device 
under investigation and includes but is not restricted to: ProGrip™ self-gripping polyester mesh. 
 
 

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Table 4: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or 
unanticipated 
 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices or comparators. 
(ISO 14155:2020, 3.2) 
Adverse Device Effect (ADE) 
AE related to the use of an investigational medical device 
 
NOTE 1: This definition includes AEs resulting from insufficient or 
inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the investigational 
medical device. 
NOTE 2: This definition includes any event resulting from an error 
use or from intentional misuse of the investigational medical 
device.  
NOTE 3: this includes ‘comparator’ if the comparator is a medical 
device. (ISO 14155:2020, 3.1) 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety or performance.  
 
NOTE 1: DD include malfunctions, use errors and inadequacy in the 
information supplied by the manufacturer including labeling.  
NOTE2: This definition includes device deficiencies related to the 
investigational medical device or the comparator. (ISO 14155:2020, 
3.19) 
 
 

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Relatedness 
Mesh 
Placement 
Procedure 
Related 
An AE that occurs due to any procedure related to the implantation 
or surgical modification of the device. 
Index Procedure Related 
An AE that occurs due to the standard of care index surgical 
procedure 
Device Related 
An AE that results from the presence or performance (intended or 
otherwise) of the device. 
Seriousness 
Serious Adverse Event (SAE) 
AE that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users or other 
persons as defined by one or more of the following:  
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, including chronic disease, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to a 
body structure or a body function, 
c) foetal distress, foetal death or a congenital abnormality or birth 
defect including physical or mental impairment 
 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in 
health, is not considered an SAE. 
(ISO 14155:2020, 3.45)  
Serious Adverse Device Effect 
(SADE)  
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
(ISO 14155:2020, 3.44)  
Other 
Anticipated Adverse Event 
An AE inherent to a surgical procedure that is expected to occur in 
all subjects for a projected duration according to the Investigator’s 
opinion, including, but not limited to:  
 
Postoperative transient nausea determined to be 
procedure related within the first 24 postoperative hours. 
 
Postoperative transient emesis determined to be 

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procedure related within the first 24 postoperative hours. 
 
Postoperative constipation determined to be procedure 
and/or medication related for the duration of medication 
administration for management of pain. 
 
Postop pain that the Investigator considers common and 
within normal limits for the procedure and is well-
managed with medication. 
Unanticipated Serious Adverse 
Device Effect (U(S)ADE)  
(Serious adverse) device effect which by its nature, incidence, 
severity or outcome has not been identified in the current risk 
assessment 
 
NOTE 1: ASADE is an effect which by its nature, incidence, severity 
or outcome has been identified in the risk assessment.  
 
(ISO 14155:2020, 3.51) 
 
Serious Health Threat  
Signal from any adverse event or device deficiency that indicates 
an imminent risk of death or a serious deterioration in the health 
in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons 
 
NOTE 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals.  
 
(ISO 14155:2020, 3.46) 
 
13.5 Reporting of Adverse Events 
The following events are generally considered reportable during the course of this study and should be 
reported to the sponsor: 
 
any DD,  
 
any procedure or device related AE or SAE, 
 
any Device Deficiency/Malfunction that might have led to an SADE if, 
o suitable action had not been taken or, 
o intervention had not been made or, 
o if circumstances had been less fortunate, 
 
new findings/updates in relation to already reported events.  
Events will be reviewed by the sponsor to determine any reporting obligations to EC. 

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SAEs & Device Deficiencies/Malfunctions that might have led to an SADE need to be reported to the 
sponsor within 24 hours of becoming aware by completing an AE report form and sending it to Medtronic 
BOX 
. When the AE report form is received by the 
sponsor, it will be marked as received and reviewed and saved in TMF. A deviation form is required if AE 
report form is not completed and AE was only reported via email to sponsor or if the event was reported 
outside of the required timeframe. Refer to Table 5 for reporting requirements of applicable events and 
device deficiencies. 
Table 5: Reporting requirements of applicable events and device deficiencies. 
Report 
Responsible party 
Submit to  
Description / Time constraints 
ADE, or DD 
Investigator 
Medtronic 
Notify within 24h of notification of 
the event via data entry into Club 
Hernie database and AE form, 
telephone call and fax 
Medtronic 
EC 
Review within 48 hours per EC 
requirements  
SAE, SADE, or 
Device Deficiency 
that might have led 
to a SADE 
Investigator  
Medtronic 
Notify within 24h of notification of 
the event via data entry into Club 
Hernie database and AE form, 
telephone call and fax 
Medtronic 
EC 
Review within 48 hours per EC 
requirements Per EC requirements 
U(S)ADE 
Medtronic 
IEC 
Review within 48 hours per EC 
requirements Per EC requirements 
Medtronic or designee 
Alternate 
applicable 
regulatory body 
Report the results of an evaluation 
to EC and all participating 
investigators within 7 working 
days after Medtronic first receives 
notice of the effect, and 2 days if 
the U(S)ADE indicates an 
imminent risk of death, serious 
injury or serious illness and 
requires prompt remedial action. 
 

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Assessment of the occurrence of an AE will be based on changes in the subject’s abbreviated physical 
examination, laboratory results and/or signs and symptoms. Adverse events will be monitored until a 
subject completes the study unless the Investigator determines the event is related to the device, in which 
case they will be monitored until resolution, if possible. Medical care will be provided, as defined in the 
informed consent, for any AE related to study participation. Adverse events will be collected on the Club 
Hernie database, and on an AE paper form to be sent to the sponsor and applicable source 
documentation. AE data will include but is not limited to; date of the AE, treatment, resolution, 
assessment of both seriousness and relationship to the investigational medical device. To the extent 
possible, the event to be recorded and reported is the event diagnosis as opposed to event symptoms 
(e.g., fever, chills, nausea and vomiting in the presence of a clinically diagnosed infection is to be reported 
as infection only). AEs occurring at procedure and up to and including 24 months follow-up will be 
recorded. 
The following should not be considered an AE: 
 
A condition requiring a preplanned procedure unless the condition worsened since screening 
 
A preexisting condition found as a result of screening, unless the condition has worsened since 
enrollment. 
All responses to the above events that require treatment beyond the institution’s standard procedures 
will be reported as AEs. 
 
All procedure AEs and ADEs as described above that are observed during the course of this study, 
regardless of severity or relationship to the device will be recorded on the appropriate the Club Hernie 
database tab and on an AE paper form. 
 
The sponsor is responsible for ensuring all Adverse Events reported by the sites are also reported to the 
EC and to Regulatory Affairs – Medtronic France as required. 
13.5.1 Adverse Event and Device Deficiency Classification 
Causality assessments define the relationship between the use of the medical device (including the 
medical-surgical procedure) and the occurrence of each adverse event, according to MEDDEV (Guidelines 
On A Medical Devices Vigilance System). The presence of confounding factors, such as concomitant 
medication/treatment, the natural history of the underlying disease, other concurrent illness or risk 
factors shall also be considered. Each AE will be classified according to five different levels of causality. 
The sponsor and the investigators will use the following definitions to assess the relationship of the serious 
adverse event to the investigational medical device or procedures: 
 
Possible Relationship: An AE that follows a reasonable temporal sequence from administration 
of the study treatment and follows a known response pattern to the study treatment but could 
have been produced by the participant’s clinical state or by other therapies. 
 
Probable Relationship: An AE that follows a reasonable temporal sequence from administration 

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of the study treatment; follows a known response pattern to the study treatment; and cannot 
be reasonably explained by the known characteristics of the participant’s clinical state or by 
other therapies. 
 
Causal Relationship: An AE that follows a plausible temporal sequence from administration of 
the study treatment and follows a known response pattern to the study treatment. The reaction 
cannot be reasonably explained by the known characteristics of the subject’s clinical state or 
other modes of therapy administered to the subject.  
 
Unknown relationship: Given the information available, sequence and timing of events, it is 
unknown or impossible to determine the relationship of the AE with the study treatment. 
The Sponsor and the Investigators will distinguish between the serious adverse events related to the 
device and those related to the index procedures and to mesh placement procedure. An adverse event 
can be related both to the index and mesh procedures and the device. Complications of procedures are 
considered not related if the PI said procedures would have been applied to the subjects also in the 
absence of device use/application. 
In some particular cases the event may be not adequately assessed because information is insufficient or 
contradictory and/or the data cannot be verified or supplemented. The sponsor and the Investigators will 
make the maximum effort to define and categorize the event and avoid these situations. Where the 
sponsor remains uncertain about classifying the serious event, it should not exclude the relatedness and 
classify the event as “possible”.  
Particular attention shall be given to the causality evaluation of unanticipated serious adverse (device) 
events. The occurrence of unanticipated events related to the use of the device (USADE) could suggest 
that the clinical investigation places subjects at increased risk of harm than was to be expected 
beforehand. 
13.6 Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following: 
 
Fatal: This event is determined to be the cause of death. 
 
Not Recovering/Not Resolved: The event has retained pathological conditions resulting from the 
prior disease or injury. 
 
Recovered/Resolved: The event has fully resolved at the end of the study. 
 
Recovering/Resolving: The event is ongoing at the end of the study. 
 
Unknown: The event has been unclassified at the end of the study. 
13.7 Study Contact Information 
Questions regarding safety or medical procedures should be directed to Medtronic MITG Medical Affairs. 
All other questions including emergency contact for reporting serious adverse events and serious adverse 
device effects should be directed to Medtronic MITG Surgical Innovations, Clinical Research. 

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Table 6: Study Contact Information 
Medical Affairs 
Clinical Research 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13.8 Subject Death 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with outcome of 
death) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one AE with the outcome of death.  
A copy of the death certificate, if available and allowed by state/local law, should be provided to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary report 
and all relevant hospital records, if available should be provided to the Medtronic clinical study team. If 
an autopsy is conducted, a copy of the autopsy report should also be provided to the Medtronic clinical 
study team if available and allowed by local law. When the death occurs at a remote study site, it is the 
investigative study site’s responsibility to attempt retrieval of information about the death.  
In summary, the following data will be collected: 
 
Date of death 
 
Detailed description of death 
 
Cause of death  
 
Relatedness to system and/or procedure 
 
Device disposition information 
 
Death summary/hospital records (if available and allowed by local law) 
 
Autopsy report (if available and allowed by local law) 
 
Death certificate (if available and allowed by local law) 
 

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13.9 Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-released 
device during the study must be reported. The reporting of product complaints is not part of the study 
and should be done in addition to the AE reporting requirements.  Refer to local regulations for reporting 
requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
 
Abuse: Abnormal use (definition acc. #4.1 of MDR 2.12-1)  
 
Misuse: Use error (definition acc. #4.20 of MDR 2.12-1) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product. Reporting must be done immediately and via the regular channels for market-released 
products. The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures. Medtronic will notify the RAs (e.g. CA) as applicable for the following 
incidents immediately upon learning of them and is not limited to AEs and DDs only: 
 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well 
as any inadequacy in the labeling or instructions for use which led or might have led to the death 
or serious deterioration in the state of health of a patient, user, or other person. 
 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
 
Any serious deterioration in the state of health, including: 
 
Life-threatening illness or injury 
 
Permanent impairment of a body function or permanent damage to a body structure 
 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
14. Data Review Committees  
Due to the design of this post-market study in association with Club Hernie, it was determined that a 
Data Monitoring Committee and Clinical Events Committee would not be chosen specifically, but that 
the study Steering Committee would review the data as needed. See section 7.3 Study Oversight for 
details on the Steering Committee. 

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14.1 Safety Committee  
An internal Medtronic Safety Team will review the overall rates of protocol defined adverse events (SAEs 
and events related to the primary and safety endpoints) on a quarterly basis. The committee will have the 
ability to make recommendations and request further information as required. 
 
15. Statistical Design and Methods 
15.1 General Aspects of Analysis 
For each of the objectives the available data will be summarized and missing data will be discussed. The 
main analysis of the study objectives will be based on available data and missing data will not be imputed 
unless otherwise noted in the statistical analysis plan. All practical monitoring and follow-up steps will be 
taken to ensure complete and accurate data collection. Deviations to the statistical analysis plan (SAP) will 
be reported per section 11.12 (Deviation Handling).  
15.2 Analysis Execution 
Analysis will include both primary and all secondary objectives. A final report will be prepared once all 
data collection has ended and all subjects have completed the 24-month follow-up or have been exited.  
15.3 Interim Analysis 
After half the enrolled subjects complete the 1-year follow-up timepoint, an interim analysis will be 
conducted for regulatory purpose. An additional interim analysis for regulatory needs may also be 
conducted as needed.  
15.4 Endpoints 
15.4.1 Primary Endpoints 
Statistical analysis of the primary endpoint will be comparative. Binomial one-way test will be used 
to compare the observed ProGrip™ Self- gripping Polyester Mesh incisional hernia incidence rate to 
the 20% theoretical incidence rate (from no prevention population), using a two- sided alpha-level of 
5%. 
15.4.2 Other Endpoints 
Other endpoints will be analyzed using descriptive methods: 
 
Qualitative variables will be described by their absolute and relative (%) frequencies of each class 
or value, and by two-tailed 95% confidence intervals. 
 
Quantitative variables will be described by their mean, standard deviation (SD), extreme values 

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(minimum and maximum values), and number of missing data and by two-tailed 95% confidence 
intervals. 
15.5 Analysis Sets 
 
The Performance Analysis Set (PAS) includes all enrolled subjects excluding subjects who became 
pregnant during the follow-up, or subjects who undergo unscheduled abdominal surgery during 
study follow-up, which may increase the risk and cause of incisional hernia occurrence*. 
*Subject follow-up data, starting from the event’s occurrence, will be excluded/remove from the 
performance analysis. 
 
Per Protocol Analysis Set (PPAS) is a subset of PAS excluding subjects with protocol violation and 
major protocol deviation(s) that may impact the primary endpoint assessment. More precisely, 
reason for exclusion may include but is not limited to, 
 
Patient wrongly included (i.e. patient was enrolled but does not meet all the eligibility 
criteria).  
 
Failure to obtain informed consent. 
 
Deviation resulting from device use outside the recommended use in the IFU. 
 
Patient who receives the incorrect device or device is misused 
 
Safety Analysis Set includes all enrolled subjects. 
15.6 Sample Size Determination 
Sample size is determined based on primary performance endpoint, assuming the superiority of 
ProGrip™ Self-gripping Polyester Mesh use to prevent incisional hernia vs no prevention of incisional 
hernia within 2-years following a midline laparotomy procedure. 
The literature review showed an incisional hernia rate after midline laparotomies around 20% (9-16). 
Using a power (1-β) of 80% and a 5% error type I (two-sided), and considering a hypothetic incisional 
hernia rate of 10% for subjects with ProGrip™ Self-gripping Polyester Mesh, vs a theoretical hypothetic 
incisional hernia rate of 20% for subjects without any prevention following a midline laparotomy 
procedure, N= 108 evaluable subjects are required. 
Assuming an attrition rate of 20% at 2-years, N=135 subjects will need to be enrolled. 
15.7 Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
 
Enrollment will not exceed 25 subjects per site. 
In summary, potential sources of bias that may be encountered in this study have been considered and 
minimized by careful study design. 

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16. Ethics 
16.1. Statement(s) of Compliance  
This study is designed to reflect the good clinical practice (GCP) principles outlined in ISO 14155:2020. 
These include the protection of the rights, safety and well-being of human subjects, controls to ensure 
the scientific conduct and credibility of the clinical investigation and the definition of responsibilities of 
the sponsor and investigators. 
The study will also be conducted in accordance with the Declaration of Helsinki (2013). The principles of 
the Declaration of Helsinki are implemented in this study by means of the Subject Informed Consent (IC) 
process, Ethics Committee approval, study training, clinical study registration, pre-clinical testing, risk 
benefit assessment, and publication policy.  
Ultimately, all study sites in all geographies will follow and comply with: 
 
Principles of DoH 
 
The Clinical Trial Agreement (CTA) 
 
The procedures described within this CIP 
 
Local EC Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  
 
In Europe the study will be conducted in compliance with DoH version 2013.  
The study will be publicly registered prior to in accordance with the 2007 FDAAA and DoH on 
http://clinicaltrials.gov (PL 110-85, section 810(a)). This study will be publicly registered on 
www.clinicaltrials.gov prior to first enrollment. In addition, the study may be registered in local regulatory 
databases where required by local law. 
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
 
Medtronic 
 
An independent medical EC. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above-
mentioned groups prior to implementation of the revised CIP at the study site. 
This study contains 3 deviations from ISO14155:2020; 
 
To ensure only data is collected from subjects who have received ProGrip™ Self-gripping 
Polyester Mesh, a subject is considered enrolled when it is confirmed they meet all pre-operative 

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inclusion and no exclusion criteria, the ICF is signed and they have been implanted with the 
device. Those subjects who sign the ICF but do not receive ProGrip™ Self-gripping Polyester Mesh 
will not be included in the study. 
 
As an on-label Post-Market Clinical Follow-up study to confirm the efficacy and safety of 
ProGrip™ Self-gripping Polyester Mesh for suture line reinforcement, only device and procedure 
related AEs will be collected. Non-related AEs (flu, broken limbs, etc.) will not be collected. 
 
The Club Hernie Data base does not have the capabilities to maintain an audit trail, data trail and 
edit trail.  The sponsor will review all database entries monthly and file securely as an audit trail. 
17. Study Administration 
17.1. Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of this study.  Trained Medtronic 
personnel or delegates appointed by Medtronic may perform study monitoring in order to ensure that 
the study is conducted in accordance with the CIP, the CTA, and the applicable regulatory and local 
requirements. Medtronic, or delegates, must therefore be allowed direct access to the subjects’ case 
histories (clinic and hospital records, and other source data/documentation) upon request as per the IC, 
Research Authorization (where applicable) and CTA.  The principal investigator should also be available 
during monitoring visits. Although on-site monitoring is preferred, remote study monitoring is also 
acceptable when necessary and study sites should make all efforts to comply with the needs of the study 
monitors.  
17.1.1 Monitoring Visits 
Frequency of monitoring visits may be based upon subject enrollment, but additional visits may be 
scheduled due to study compliance, number of adverse events, number of deviations, observations from 
previous monitoring visits and any suspected inconsistency in data that requires investigation. Regulatory 
documents will be reviewed at each study site. Monitoring for the study, including site qualification visits, 
site initiation visits, interim monitoring visits, and closeout visits, will be done in accordance to the study-
specific monitoring plan. 
Monitoring visits may be conducted periodically to assess study site progress, the investigator’s adherence 
to the CIP, regulatory compliance including but not limited to EC approval and review of the study, 
maintenance of records and reports, and review of source documents against subject CRFs in accordance 
to the study-specific monitoring plan. Monitors review study site regulatory and study compliance by 
identifying observations of non-compliance and communicating those observations along with 
recommendations for preventative/corrective actions to study site personnel.  Monitors may work with 
study personnel to determine appropriate corrective action recommendations and to identify trends 
within the study or at a particular study site.  

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17.2. Data Management 
Data will be collected using an electronic database (Club Hernie) and paper CRFs. The Club Hernie 
database is free for use by surgeons. Only Hernia Club surgeon members or designees are allowed to get 
an account for the database, protected by identifier and password. Members only have access to their 
data and cannot view or modify/manipulate other member’s data. Data entered into the database is 
required to be completed pseudonymously. Therefore, it does not contain any patient data such as name, 
date of birth, social security number or address of the patient. Club Hernie maintains a list of individuals 
who have access to the database. 
Database extractions will be transferred by a Club Hernie representative to sponsor securely by upload 
into Medtronic Box. All database extractions will be retained for audit and inspection purposes. Data 
review of all new, updated and previously entered data will be performed after receipt of each database 
extraction to ensure the accuracy of the report and identify possible data discrepancies by Medtronic and 
Data Clarification Forms will be issued to the sites for appropriate response. The site staff will be 
responsible for resolving all queries in the database. All discrepancy resolutions will be retained for audit 
and inspection purposes in a discrepancy tracker. 
Adverse Events will be coded per Medical Dictionary for Regulatory Activities (MedDRA).  
All records and other information about subjects participating in this study will be treated as confidential.     
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
study site. Source documents, which may include worksheets or subject medical records, must be created 
and maintained by the investigational study site team.  
The investigator will clearly mark clinical records to indicate that the subject is enrolled in this clinical 
investigation.  
Paper CRFs will consist of Inclusion Form, AE Form, DD Form, Protocol Deviation and Study Exit Form.   The 
data reported on the CRFs and into Club Hernie shall be derived from source documents and be consistent 
with these source documents, and any discrepancies shall be explained in writing. Please refer to section 
11.11 Data Recording for exceptions to this requirement. 
17.3. Direct Access to Source Data/Documents  
Medtronic may conduct audits at participating study sites. The purpose of an audit is to verify the 
performance of the monitoring process and the study conduct, independently of the personnel directly 
involved in the study. Regulatory authorities (RAs) may also perform inspections at participating study 
sites. The investigator and/or institution shall permit Medtronic, ECs and RAs direct access to source data 
and documents during monitoring, audits and regulatory inspections. 

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17.4. Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by the applicable 
laws and/or regulations, will not be made publicly available. Subject names will be kept confidential. Only 
the site identification number and subject number will be recorded in the Club Hernie electronic database, 
and if the subject name appears on any other document, it must be redacted. Study findings stored on a 
computer will be stored in accordance with local data protection laws. The subjects will be informed in 
writing that representatives of the sponsor, EC, or Regulatory Authorities may inspect their medical 
records to verify the information collected, and that all personal information made available for inspection 
will be handled in strictest confidence and in accordance with local data protection laws. Subjects will also 
be informed that information regarding the study that does not include subject identifiers will be posted 
on clinicaltrials.gov. When the results of the study are published, the subject’s identity will remain 
confidential. The investigator will maintain a master list to enable subjects’ records to be identified. 
17.5. Liability  
17.5.1. 
Warranty 
Sofradim Production is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate clinical study liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical study insurance statement/certificate will be provided to the EC. 
Subjects will not be provided with compensation for participation in this study.  
 
17.6. CIP Amendments 
A CIP/Protocol amendment will be prepared when there are revisions that are significant changes or 
corrections, or modification that impact subject safety, ethical conduct, data integrity or study design. 
CIP/Protocol amendments must undergo review and approval by the sponsor, EC and any appropriate 
regulatory authority, and will be logged in the document version history (Section 20). EC approval 
regulatory authority approval (if applicable), site training and a new Investigator Commitment form will 
be signed and returned before any new procedures take place. 
17.7. Record Retention 
The investigator and the sponsor will maintain the records of the study including all pertinent 
correspondence, the study protocol with any/all amendments, all correspondence with and approval from 
the EC, the Investigator Agreement, device accountability records, individual subject records, and signed 
informed consent forms. Subject files, other source data and essential documentation kept in the 
Investigator study files and should be retained until at least 2 years after the last approval of a marketing 

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application in an ICH region and until there are no pending or contemplated marketing applications in an 
ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the 
investigational product. Records may need to be maintained by the Principal Investigator for a longer 
duration if national regulations require or if agreed to in writing with Medtronic. Prior to the destruction 
of the study related data, the investigator must notify the sponsor. The principal investigator will ensure 
that essential study documents are not destroyed until written permission has been obtained from 
Medtronic. All data and documents should be made available if requested by relevant authorities.  
After closure of the study Medtronic will archive records and reports per Medtronic standards and 
applicable regulations. 
17.8. Reporting Requirements 
17.8.1. 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all case report forms, adverse events and adverse device effects (reported per the country-specific 
collection requirements), device deficiencies, deaths, and any deviations from the clinical investigation 
plan. Any deviation from the clinical investigational plan shall be recorded together with the explanation 
of the deviation. Notice of deviations from the CIP to protect the life or physical well-being of a subject in 
an emergency shall be given as soon as possible, but no later than 5 working days after the emergency 
occurred.  Except in such emergency, prior approval is required for changes in the plan or deviations.   
Table 7: Investigator reports applicable to Europe, Middle East and Africa per ISO 14155 
Report 
Submit to 
Description/Constraints 
Study Deviations 
Sponsor  
Any deviation from the CIP shall be recorded together with 
an explanation for the deviation.  Deviations shall be 
reported to the sponsor who is responsible for analyzing 
them and assessing their significance.   
Note: When relevant, ethics committees, CAs or the 
appropriate RAs should be informed. (ISO 14155:2020) 
Failure to obtain IC 
Sponsor  
IC shall be obtained in writing and documented before a 
subject is enrolled into the clinical investigation.  (ISO 
14155:2020) 
 
 
 

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17.8.2. 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
table below.  In addition to the reports listed below, Medtronic shall, upon request of the reviewing EC or 
RA, provide accurate, complete and current information about any aspect of the investigation.  
Table 8: Sponsor reports for Europe, Middle East and Africa 
Report 
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
EC, 
Relevant authorities and 
Head of the Institution 
Provide prompt notification of termination or 
suspension and reason(s). (ISO 14155:2020) 
Withdrawal of EC 
approval 
Investigators, 
Head of Institution, 
EC and 
relevant authorities 
Investigators, ECs will be notified only if required by 
local laws or by the EC. 
Withdrawal of CA 
approval 
Investigators, 
Head of Institution, 
EC, and 
relevant authorities 
Investigators, ECs will be notified only if required by 
local laws or by the EC. 
Progress Reports 
EC and 
RAs 
This will be submitted to the EC only if required by the 
EC). 
Final report 
Investigators, 
EC, and 
RAs if required 
For studies with study sites complying to ISO 14155: 
 
The investigator shall have the opportunity to 
review and comment on the final report.   
 
If a clinical investigator does not agree with the 
final report, his/her comments shall be 
communicated to the other investigator(s).   
 
The coordinating investigator shall sign the 
report. If no coordinating investigator is 
appointed, then the signature of the principal 
Investigator in each study site should be 
obtained.    (ISO 14155:2020) 

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Report 
Submit to 
Description/Constraints 
Study deviation 
Investigators 
Ensure that all deviations from the CIP are reviewed 
with the appropriate clinical investigator(s), are 
reported on the CRFs and the final report of the clinical 
investigation.  (ISO 14155:2020) 
Study site specific study deviations will be submitted to 
investigators periodically.   
17.9. Publication and Use of Information 
The Medtronic Publication and Authorship Policy is aligned with the International Committee of Medical 
Journal Editors (ICMJE) recommendations (www.icmje.org). Medtronic will seek to publish, in appropriate 
peer-reviewed journals and scientific conferences, results of clinical studies where human subjects are 
involved, regardless of outcome. While study results are owned by Medtronic, all data on which a 
publication is based will be made available to all authors as required for their participation in the 
publication process. Furthermore, data may be published or used by study investigators provided that 
such publication or use is in accordance with this protocol, the Medtronic Publication and Authorship 
Policy, and the Clinical Investigation Agreement. Investigators must submit a copy of all manuscripts 
and/or abstracts to Medtronic for review and comment 30 days prior to planned submission. Medtronic 
acknowledges that its right to review and comment shall relate solely to the proprietary, licensing, and/or 
confidential rights Medtronic may have in such proposed publication, rather than whether such results 
and/or opinions are favorable to Medtronic. 
The publication of post-hoc analyses, regional results, or single-center experiences based on multicenter 
clinical studies should not precede that of the primary multicenter publication, and should cite the primary 
publication whenever possible, as required by specific journal and scientific meeting guidelines. 
Medtronic involvement in a publication (e.g., funding of the study; sponsor of the study; collection, 
analysis, and interpretation of data; professional writing assistance) must be disclosed according to 
journal-specific policies, submission requirements, and prevailing editorial standards, in addition to those 
specified by International Committee of Medical Journal Editors. Authors must ensure that an 
acknowledgement/disclosure statement is included in the body of the manuscript for Medtronic to review 
for accuracy. All authors must also disclose financial or personal affiliations that could be considered 
conflicts of interest as per journal/conference requirements. 
To enable health care providers, payers, and subjects’ access to the wealth of Medtronic’s research, 
Medtronic will report its scientific data in accordance with the principles outlined in the Guidance 
Document on Registration and Reporting Results of Company-Sponsored Clinical Trials under FDAAA 2007 
(Title VIII). 

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17.9.1. 
Transparency 
Transparency of clinical study results will be maintained by the following means: 
 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, ECs and CAs of participating countries when required by local law 
 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated  
 
Submitting for publication the primary study results after the study ends  
 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
 
Making an individual study sites study data accessible to the corresponding investigator after the 
completion of the study, if requested 
17.10. Suspension or Early Termination 
17.10.1. Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined as 
closure of a study that occurs when Medtronic and/or regulatory requirements have been satisfied per 
the CIP and/or by a decision by Medtronic or RA, whichever occurs first. The study closure process is 
complete upon distribution of the Final Report or after final payments, whichever occurs last. Ongoing EC 
oversight is required until the overall study closure process is complete. Refer to Section 11.13 for 
additional information regarding study exit procedures. 
17.10.2. Early Termination or Suspension 
Early Termination is the closure of a study that occurs prior to meeting defined endpoints. This is possible 
for the whole study or a single study site. Suspension is a temporary postponement of study activities 
related to enrollment and distribution of the product. This is possible for the whole study or a single study 
site.  
17.10.2.1. Study-wide termination or suspension 
Possible reasons for considering study-wide suspension or termination of the study include but are not 
limited to: 
 
AEs associated with the system or product under investigation which might endanger the safety 
or welfare of the subject 
 
Observed/suspected performance different from the product’s design intent 
 
Decision by Medtronic or RA (where the study is operating under RA)  
 
Technical issues during the manufacturing process 

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17.10.2.2. Investigator/ study site termination or suspension 
Possible reasons for investigator or study site termination or suspension include but are not limited to: 
 
Failure to obtain initial EC approval or annual renewal of the study 
 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
 
Lack of enrollment 
 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring observations in a timely manner, 
etc.)  
 
EC suspension of the study site 
 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
 
Investigator request (e.g. no longer able to support the study)  
17.10.3. Procedures for Termination or Suspension 
17.10.3.1. Medtronic-initiated and regulatory authority-initiated 
 
Medtronic will promptly inform the clinical investigators of the termination or suspension and the 
reasons and inform the RAs where required 
 
In the case of study termination or suspension for reasons other than a temporary EC approval 
lapse, the investigator will promptly inform the EC  
 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
17.10.3.2. Investigator-initiated 
 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
 
The investigator will promptly inform the institution (where required per regulatory 
requirements)  
 
The investigator will promptly inform the EC 
 
the investigator will promptly inform the regulatory authorities, if applicable 
 
The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 

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17.10.3.3. Ethics committee-initiated 
 
Subject enrollment must stop until the suspension is lifted 
 
Subjects already enrolled should continue to be followed in accordance with EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
 
The investigator will inform his/her institution (where required per local requirements)  
 
The investigator will promptly inform the subjects or the personal physician of the subjects, with 
the rationale for the study termination or suspension 
 
the investigator will promptly inform the RAs 
 
 

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18. References 
1. 
Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM. Elective midline laparotomy closure: the INLINE 
systematic 
review 
and 
meta-analysis. 
Ann 
Surg. 
2010;251(5):843-56. 
doi: 
10.1097/SLA.0b013e3181d973e4. PubMed PMID: 20395846. 
2. 
Pereira JA, Pera M, Grande L. [Incidence of incisional hernia after open and laparoscopic colorectal 
cancer resection]. Cir Esp. 2013;91(1):44-9. doi: 10.1016/j.ciresp.2012.05.004. PubMed PMID: 
22769029. 
3. 
Moussavian MR, Schuld J, Dauer D, Justinger C, Kollmar O, Schilling MK, et al. Long term follow up 
for incisional hernia after severe secondary peritonitis-incidence and risk factors. Am J Surg. 
2010;200(2):229-34. doi: 10.1016/j.amjsurg.2009.08.043. PubMed PMID: 20122679. 
4. 
van 't Riet M, Steyerberg EW, Nellensteyn J, Bonjer HJ, Jeekel J. Meta-analysis of techniques for 
closure of midline abdominal incisions. Br J Surg. 2002;89(11):1350-6. doi: 10.1046/j.1365-
2168.2002.02258.x. PubMed PMID: 12390373. 
5. 
Bresnahan E, Bates A, Wu A, Reiner M, Jacob B. The use of self-gripping (Progrip) mesh during 
laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term 
outcomes study. Surg Endosc. 2015;29(9):2690-6. doi: 10.1007/s00464-014-3991-y. PubMed PMID: 
25519425. 
6. 
Hopson SB, Miller LE. Open ventral hernia repair using ProGrip self-gripping mesh. Int J Surg. 
2015;23(Pt A):137-40. doi: 10.1016/j.ijsu.2015.09.069. PubMed PMID: 26433025. 
7. 
Birk D, Hess S, Garcia-Pardo C. Low recurrence rate and low chronic pain associated with inguinal 
hernia repair by laparoscopic placement of Parietex ProGrip mesh: clinical outcomes of 220 hernias 
with mean follow-up at 23 months. Hernia. 2013;17(3):313-20. doi: 10.1007/s10029-013-1053-3. 
PubMed PMID: 23412779. 
8. 
Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial 
comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open 
inguinal hernia repair. Br J Surg. 2014;101(11):1373-82; discussion 82. doi: 10.1002/bjs.9598. 
PubMed PMID: 25146918. 
9. 
Abo-Ryia MH, El-Khadrawy OH, Abd-Allah HS. Prophylactic preperitoneal mesh placement in open 
bariatric surgery: a guard against incisional hernia development. Obes Surg. 2013;23(10):1571-4. doi: 
10.1007/s11695-013-0915-1. PubMed PMID: 23512444. 
10. Curro G, Centorrino T, Low V, Sarra G, Navarra G. Long-term outcome with the prophylactic use of 
polypropylene mesh in morbidly obese patients undergoing biliopancreatic diversion. Obes Surg. 
2012;22(2):279-82. doi: 10.1007/s11695-011-0486-y. PubMed PMID: 21809056. 
11. Curro G, Centorrino T, Musolino C, Sarra G, Navarra G. Incisional hernia prophylaxis in morbidly obese 
patients 
undergoing 
biliopancreatic 
diversion. 
Obes 
Surg. 
2011;21(10):1559-63. 
doi: 
10.1007/s11695-010-0282-0. PubMed PMID: 20853159. 
12. El-Khadrawy OH, Moussa G, Mansour O, Hashish MS. Prophylactic prosthetic reinforcement of 
midline abdominal incisions in high-risk patients. Hernia. 2009;13(3):267-74. doi: 10.1007/s10029-
009-0484-3. PubMed PMID: 19262985. 
13. Garcia-Urena MA, Lopez-Monclus J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavon CC, et al. 
Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional 
hernia in colorectal surgery. Ann Surg. 2015;261(5):876-81. doi: 10.1097/SLA.0000000000001116. 
PubMed PMID: 25575254. 

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14. Gutierrez de la Pena C, Medina Achirica C, Dominguez-Adame E, Medina Diez J. Primary closure of 
laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. 
Hernia. 2003;7(3):134-6. doi: 10.1007/s10029-003-0124-2. PubMed PMID: 12687426. 
15. Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of 
Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open 
bariatric surgery. Surgery. 2014;156(4):902-8. doi: 10.1016/j.surg.2014.06.022. PubMed PMID: 
25239343. 
16. Strzelczyk JM, Szymanski D, Nowicki ME, Wilczynski W, Gaszynski T, Czupryniak L. Randomized clinical 
trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006;93(11):1347-50. 
doi: 10.1002/bjs.5512. PubMed PMID: 17006977. 
 
 
 

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19. Appendices  
19.1. APPENDIX A: List of Investigators and Institutions 
Investigational Sites information including addresses, contact information, Principal Investigators, and the 
EC will be retained in a separate document from the body of the clinical investigation plan document. This 
will be provided to investigational sites and updated as necessary. 
 
 

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19.2. APPENDIX B: Instructions for Use 
 

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19.3. APPENDIX C: Financial Statement 
Medtronic contracts with participating institutions/investigators through a Clinical Trial Agreement (CTA) 
that defines the scope and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic.  
The CTA will be retained in the Trial Master File per the Document Management Plan. 
 
19.4. APPENDIX D: Subject Forms 
Site-specific Patient Informed Consent (PIC) templates will be retained in a separate document from the 
body of the clinical investigation plan document. This will be provided to investigational sites and updated 
as necessary. 
 
 

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19.5. APPENDIX E: Subject Enrollment Decision Tree 
 

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20. Version History  
Version 
Summary of Changes 
Author(s)/Title 
1.0 
‘Not Applicable, New Document’ 
 
Senior Medical Writer 
2.0 
 
Minor typos correction 
 
Title: Correction of the title, subject has replaced 
patient by error in version 1.0. 
 
Front page: Confidentiality Statement: added 
Sofradim Production to indicate relationship with 
Medtronic plc. 
 
Section 2. Deletion of FAS definition as it is not used 
in the CIP, correction of PPAS definition and addition 
of PAS and SAS definition. 
 
Section 3. Update of synopsis for the title and 
statistical section 
 
Section 6.1. Addition of the use of the AE report form 
for safety reporting to be complaint with section 11. 
 
Section 9.6. Correction of example for major 
deviation  
 
Section 9.7.2 and 9.7.4 Clarification that screen 
failure and withdrawal will also be recorded in the 
POETRY Study Exit Form. 
 
Section 9.7.3. Addition that reason for 
discontinuation will be clearly recorded in the 
applicable POETRY Study Exit Form and Club Hernie 
Registry Database 
 
Section 9.7.5. Clarification that attempts to contact 
Lost to Follow-Up patient must be documented. 
 
Section 11.1.6. Addition of RA Medtronic France 
email. 
 
Section 11.2. update of study email for the reporting 
of AE. 
 
Section 11.3 Study Contact Information update 
 
Section 13. Addition of Per Protocol Analysis Set 
definition 
Appendix B. Update of IFU 
 
Clinical Study Manager 
3.0 
 
Change of template 056-F275, v A Clinical 
Investigation Plan Template 
 
Section 2. Addition of EU MDR definition  
 
Section 3. Clarification of Clinical Study type 
 
Clinical Study Manager 

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 
Section 3. Update of inclusion/exclusion criteria and 
Study Procedures and Assessments per change in 
section 8.2, 8.4 and 9.1.2 
 
Section 5. Update of section title per new template 
 
Section 6. Change of sub-section categories per the 
new template 
 
Section 8.3. Clarification of the risk factors linked to 
hernia history 
 
Section 8.4. Clarification of exclusion criteria #2 by 
highlighting two contra-indications 
 
Section 9.1.2 Addition of the pregnancy test (for 
exclusion criteria) 
 
Section 9.7.2 Deletion of record of screen Failure in 
the Club Hernie database 
 
Section 11.2. Addition of reporting requirement to RA 
Medtronic France per 056-G140 Global Safety 
Reporting Requirements for Clinical Studies 
 
Section 14.1 Addition of the EU MDR for study 
compliance 
4.0 
 
Change of template 056-F275, v B Clinical 
Investigation Plan Template 
 
Document updated for ISO14155:2020 
 
Document updated to allow for up to 12 sites  
 
Document updated for minor typos 
 
Document updated to clarify Sponsor vs Local 
Sponsor 
 
Glossary updated to include additional terms and 
abbreviations 
 
Section 1 Investigator Statement is now called the 
Investigator Commitment 
 
Section 4 Synopsis section updated to reflect 
document changes  
 
Section 6.2.2 updated to include additional secondary 
endpoint 
 
Section 7 Study Design has been updated 
 
Section 7.3 Study Oversight section added 
 
Section 8 Product Description updated to include 
additional meshes 
 
Section 8.5 updated to clarify product training 
requirements 
, 
Senior Medical Writer 

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 
Sections 8.7 Product Storage added 
 
Section 8.8 Product Return and 8.9 Product 
Accountability have been updated 
 
Section 9 Study Site Requirements added 
 
Section 10.2 Subject Enrollment has been edited for 
clarity 
 
Section 10.3 Inclusion Criteria has been updated 
 
Section 10.4 Exclusion Criteria has been updated 
 
Section 11.1 Schedule of Events has been updated 
 
Section 11.2 Data Collection has been updated 
 
Section 11.2 Table 2 updated to clarify adverse event 
collection to occur at all visits 
 
Section 11.3 Scheduled Follow-up Visit Windows has 
been added 
 
Section 11.5 Subject Consent updated 
 
Section 11.7 Scheduled Follow-up Visits has been 
edited for clarity 
 
Section 11.8 Subject Questionnaires has been added 
 
Section 11.11 Recording Data has been updated 
 
Section 11.12 Deviation Handling has been updated  
 
Section 11.13.1. Study Exit has been updated 
 
Section 11.13.5 Lost to Follow-up has been updated 
with details 
 
Section 11.13.6 updated to clarify when to exit a 
subject if a mesh has been removed 
 
Section 11.13.7 Study Completed has been added 
 
Section 12.1 Potential Risks has been updated  
 
Section 12.2 Risk Minimization has been updated  
 
Section 13 Adverse Events and Device Deficiencies 
updated 
 
Section 13.1 updated to clarify procedure related 
adverse events 
 
Section 13.8 Subject Death added 
 
Section 13.9 Product Complaint Reporting added 
 
Section 14 Data Review Committees updated 
 
Section 15 Statistical Design and Methods updated 

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 
Section 15.3. updated to allow for an additional 
interim analysis 
 
Section 16.1 Statement(s) of Compliance updated 
 
Section 17.1 Monitoring updated for remote 
monitoring 
 
Section 17.2 Data Management has been updated 
 
Section 17.3 Direct access to Source Data/Document 
updated 
 
Section 17.8 Reporting requirements added 
 
Section 17.10 Suspension or Early Termination 
updated 
 
Appendix B added in additional IFU for additional 
meshes 
 
Appendix E Subject Enrollment Decision Tree added