MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PRECLUDE PERICARDIAL MEMBRANE; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Death (1802)

Event Date 01/12/2021

Event Type  Death  

Manufacturer Narrative

Per the gore¿ preclude pericardial membrane instruction for use.Adverse events associated with the use of the membrane may include, but are not limited to: adhesions.Lot # and implant / explant date are unknown.

Event Description

The following publication was reviewed: a case of recurrent constrictive pericarditis induced by pericardial substitution with an expanded polytetrafluoroethylene membrane a (b)(6)-year-old man presented with recurrent constrictive pericarditis, which developed 6 months after pericardiectomy, and pericardial substitution with an expanded polytetrafluoroethylene membrane.Re-pericardiectomy was performed.A new thick membranous structure had grown under the expanded polytetrafluoroethylene membrane anterior to the right ventricle, and was firmly adhered to the epicardium.This new structure exhibited collagenous fiber-based fibrotic thickening, and resembled a foreign body reaction.It was surmised that recurrence of constrictive pericarditis may have been induced by the expanded polytetrafluoroethylene membrane.Heart failure resolved after the operation; however, the patient died of respiratory failure on postoperative day 6.

• Brand Name: GORE PRECLUDE PERICARDIAL MEMBRANE
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11231081
• MDR Text Key: 228710538
• Report Number: 3003910212-2021-01155
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR