FDA Contegra Pulmonary Valved Conduit H020003 Instructions

Contegra® Pulmonary Valved ConduitH020003

Presentation to the Pediatric Advisory Committee September 12, 2017

Dora Vega, MD, PhDDivision of EpidemiologyOffice of Surveillance and BiometricsCenter 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

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

* 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 ProblemComparison of MDRs – 2016 and 2017

*. One MDR involved a potential tracheal compression.

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

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 reportthe following to the PAC in 2018:
• Device Annual Distribu)on Numbers
• MDR Data
• Literature Review

Questions to the PAC

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

(*) Slides prepared by