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

Catalog Number PSM-01060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hematoma (1884); Unspecified Respiratory Problem (4464)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2022, the patient visited the hospital and complained of chest pain and that it was hard to breath with pressure.An exam suspected a gossypiboma.Considering the patient had experienced cardiac surgery 3 times in the interim, a surgery was performed and a sheet was found.A hematoma was found on the back side of the sheet.No gauze was found.The sheet was explanted and the symptoms improved.It was reported the sheet was implanted when the patient underwent an aortic valve replacement for an aortic regurgitation about 30 years ago, on (b)(6) 1990.The explanted device was returned for evaluation.The submitted specimen was consistent with a gore® preclude® pericardial membrane.

Manufacturer Narrative

Patient date of birth and gender were requested but not available.Lot # was requested but not available code (b)(4): a review of the manufacturing records could not be performed as the lot # was not available.Code (b)(4): the device was returned for explant evaluation.Explant evaluation results: the submitted specimen is consistent with gore® preclude® pericardial membrane.The biomaterial membrane appeared structurally normal with no evidence of tissue integration.There were scattered plaques of degenerate blood or thrombus overlying the surface.Scattered foci of calcification were present in both sections with one small region of the membrane fully calcified.The great majority of the membrane examined was devoid of calcification.The overall impression is of normal appearance of the membrane and the expected tissue response for a long-term implant.

• 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): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14999421
• MDR Text Key: 295771487
• Report Number: 3007284313-2022-02028
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PSM-01060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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): Required Intervention
• Patient Weight: 52 KG