FDA Contegra Pulmonary Valved Conduit H020003 Instructions

: June 7, 2024
: FDA

Table of Contents

Device Description
Annual Distribution Numbers
Medical Device Report (MDR) Review
MDR: Poten<al Tracheal Compression
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

Contegra® Pulmonary Valved Conduit
H020003

Presentation to the Pediatric Advisory Committee September 12, 2017

Dora Vega, MD, PhD
Division of Epidemiology
Oﬃce of Surveillance and Biometrics
Center for Devices & Radiological Health

Device Description

A glutaraldehyde-crosslinked, heterologous bovine jugular vein with a competent tri-leaﬂet venous valve
Indica)ons for Use Correc)on or reconstruc)on of the right ventricular outflow tract (RVOT) in pa)ents aged < 18 years with any of the following congenital heart malformed)ons
Pulmonary Stenosis (PS)
Tetralogy of Fallot (TOF)
Truncus Arteriosus (TA)
Pulmonary Atresia (PA)
Transpose)on with Ventricular Septal Defect (VSD) , and
– Replacement of previously implanted, but dysfunc)on, pulmonary homografts or valved conduits

Annual Distribution Numbers

The HDE Annual Distribu)on Number (ADN) is currently deﬁned as the number of devices reasonably needed to treat, diagnose, or cure a popular)on of 8,000 individuals in the United States
The ADN for Contegra is 4,000 (based on original device approval)
Since the last PAC review
372 sold
172 implanted: at least 163 implanted in pediatric (< 22-year-old) pa)ents

Medical Device Report (MDR) Review

Date: 06/01/16 – 05/31/17
109 MDRs: 84 unique events: 1 death (pediatric), 83 injuries

Demographic Data	Value	MDRs containing demographic
Country	US: OUS	89% : 11%

MDR: Primary Reported Event
**by Patient Age and TTEO*
(MDR Date: 06/01/16 – 05/31/17)**

Primary Reported Event

| ****

MDR

(n)

| MDR by Patient Age (year)| TTEO (month)
---|---|---|---
Pediatric ( < 22)| Adult ( > 22)| Age not reported| ****

Range

| Mea n
Stenosis| 37| 36| 1| | 3 — 160| 73
The device replaced (reason not provided)| 35| 34| | 1| ****

3 — 158

| ****

71

Regurgitation| 5| 4| 1| | 50 — 136| 87
Arrhythmia| 2| 2| | | 0 — 0.3| 0.15
Aneurysm| 1| 1| | | 17| ——
Infection/Endocarditis (1 Death)| 2**| 2| | | 0.5 — 37| 19
Increased pressure gradient| 1| 1| | | 133| ——
Thrombus| 1| 1| | | 0.07| ——
Total| 84| 81| 2| 1|

Time to Event Occurrence (TTEO)
** One MDR involved a potential tracheal compression. A total of 83 MDRs were injuries.

MDR: Poten<al Tracheal Compression

Case Summary (Updated on 9-8-2017)

Male neonate with a history of Truncus arteriosus type II corrected with a 14 mm Contegra implant and Rastelli procedure
Conduit replaced with a 12 mm Contegra for unclear reasons 2 weeks aYer ﬁrst implant
– Issues reported included high airway pressure and suspected tracheal compression
The patient expired 6 days aYer Contegra replacement
Cause of death: Pneumonia and Sepsis (unrelated to Contegra)

MDR: Primary Reported Problem
Comparison of MDRs – 2016 and 2017

Primary Reported Event	2016 PAC	2017 PAC
MDR Count (%)	MDR Count (%)
Stenosis	28 (48 %)	37 (44 %)
Device replacement (reason not provided)	22 (38 %)	35 (42 %)
Regurgitation	2 (3.4 %)	5 (6 %)
Arrhythmia	0	2 (2.3 %)
Aneurysm	0	1 (1.3 %)
Infection/Endocarditis*	2 (3.4 %)	2 (2.3 %)
Increased pressure gradients	1 (1.7 %)	1 (1.2 %)
Thrombus	0	1 (1.2 %)
Conduit tear/breakdown	2 (3.4 %)	0
Device sizing issue	1 (1.7 %)	0
Total	58	84

*. One MDR involved a potential tracheal compression.

Records identiﬁed through PubMed and Embase (06/01/16- 05/31/17) (n = 58)| Duplicates Excluded (n=7
---|---
Titles and abstracts reviewed (n=51)| Records Excluded (n= 26)

Non—relevant to Contegra (n=12)
Past Reviews (n =7)
Abstracts, no full text (n=3)
In–vitro Study (n=2)
Oﬀ—label use (LVOT placement, (n=1)
Animal Study (n=1)

Full text articles assessed for eligibility
(n = 25)| Reviewed and excluded articles (n=24)

Other Xenograft/device (n=12)
Combined data (n=2)
Review article (n=4)
Non—relevant (Melody) (n=1)
Unreported outcome (n=2)
Modiﬁed device (n=1)
Non—clinical study (n=1)
Foreign Language (n=1)

The article included in the ﬁnal review (n =1) 1 Case report

Case Report – 1 pa <ent
Falchettiet al. 2016
Contegra 12 mm: How Long Can It Last? World J
for Pediatric and Congenital Heart Surgery. 2016
Belgium

16 years freedom from failure -12 mm Contegra Background -Pre-implanta <on

Pa<ent: 4 mo. old female (wt. 3kg) referred from another country with Type 1 TA, large VSD, RVH, right-sided or)c arch, grade 2/4 valve regurgitate)on, and well developed PA branches
Implanta<on and Hospital Course:
RVOT reconstruc)on with 12 mm Contegra
The Main PA diameter measured 9 mm
PA diameter mismatch results in a Z-score of + 2.5
Pa)ent discharged POD16 for follow-up at referring country

TA= truncus arteriosus, VSD= ventricular septal defect, RVH= right ventricular hypertrophy, PA = pulmonary artery, PH = pulmonary hypertension, POD= post opera)on date

16 years -Post-implantation

Referred for reopera)on due to conduit failure
Healthy female : wt. 33kg/73 lbs; ht.156 cm/5’2”
TTE: competent truncal valves, conduit stenosis, 110 mm Hg RVOT gradient, no regurgita)on, and normal RV and LV function
CT scan: conduit diameter shrinkage to 9 mm and calciﬁca)on
Replaced with a 22 mm pulmonary homography Poten<al factors contribu<ng to 16 years of freedom from failure
Moderate oversizing: Z score of +2.5
Suturing technique: Distal every suture, potentially contributing to avoidance of distal stenosis

RH= right heart, RVOT= right ventricular ouRlow tract, RV= right ventricle, LV= leY ventricle, TTE= Transthoracic Echocardiography, CT= computed tomography

FDA Conclusions

MDR data review idetiﬁed a case of conduit replacement for an unclear reason(s). The FDA believes that currently there is insuﬃcient information to determine if this was a case of tracheal compression due to the device
Other Adverse Events reported in MDRs are known events addressed in the device IFU
No new concerns were reported in the literature

FDA Recommendations

FDA will con)nue the conversa)on with the manufacturer for additional information regarding the suspected case of tracheal compression
FDA will continue device surveillance and report
the following to the PAC in 2018:
Device Annual Distribu)on Numbers
MDR Data
Literature Review

Questions to the PAC

Does the Commi4ee agree with CDRH’s conclusions and recommendations about surveillance and report of ADN, MDRs, and literature review?
Does the Commi4ee have any additional comment(s)?

Oﬃce of Device Evaluation
Jonathan Reich
Changfu Wu| Oﬃce of the Center Director
Nia Benjamin
Vasum Peiris
Victoria Wagman
---|---
Oﬃce of Surveillance and Biometrics
George Aggrey
Kelly Bauer
Jiping Chen
Jose Delgado Donayre
Benjamin Eloﬀ
Chih-Hsin “Jenny” Liu
Greg O’Connell
Nadezda Radoja
Erika Tang
Dora Vega
Aron yustin| Oﬃce on Pediatrics and Therapeutics
Judith Cope,
Robert “Skip” Nelson
Amy Odegaard
Kenneth Quinto
Pam Weinel