GORE PRECLUDE Pericardial Membrane 1PCM102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132601837), received between Mar 9, 2021 and Dec 22, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING INFORMATION WAS REPORTED TO W. L. GORE & ASSOCIATES: "MY CHILD WAS IMPLANTED WITH A 'MASA VALVE' IN 2017 BUILT WITH THE OFF LABEL USE OF GORETEX STRETCH GRAFT AND PRECLUDE PERICARDIAL MEMBRANE. THE VALVE FAILED IN 2021. MULTIPLE ISSUES WERE IDENTIFIED BY THE SURGEON WHO REMOVED THE MASA VALVE, ONE: THE STITCHING OF THE SUTURES OF A LEAFLET TEARING AND THE LEAFLET ¿WAS FLOPPING IN THE WIND¿ IT IS NOT YOUR PRODUCT THAT FAILED BUT THE OFF LABEL USE BY THE SURGEONS WHO FAILED TO GIVE INFORMED CONSENT THAT FAILED MY CHILD." ADDITIONAL INFORMATION RECEIVED ON DECEMBER 8, 2023, VIA MEDICAL RECORDS: ON (B)(6) 2017 - AORTIC VALVE REPAIR. ON (B)(6) 2017 - PATIENT DEVELOPED SEVERE AORTIC INSUFFICIENCY AFTER VALVE REPAIR. ON (B)(6) 2017. PATIENT TAKEN BACK TO OPERATING ROOM FOR A ROSS PROCEDURE USING A GORE® PRECLUDE® PERICARDIAL MEMBRANE AND A GORE-TEX® STRETCH VASCULAR GRAFT FOR REPLACEMENT OF THE NATIVE PULMONARY VALVE AND PULMONARY ARTERY. THE PATIENT PRESENTED IN (B)(6) 2022 WITH STENOSIS OF THE CONDUIT AND SEVERE PULMONARY REGURGITATION. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE AND A GORE-TEX® STRETCH VASCULAR GRAFT WERE EXPLANTED ON (B)(6) 2022. ADDITIONAL NOTE: IT WAS REP

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 18380741 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE: UNICUSPID AORTIC VALVE REPAIR WITH BICUSPIDIZATION IN THE PAEDIATRIC POPULATION. MATSUSHIMA S, HESS A, LAMMERZAHL JR, KARLIOVA I, ABDUL-KHALIQ H, SCHAFERS H-J. EUR J CARDIOTHORAC SURG 2020; DOI:10.1093/EJCTS/EZAA285. THE ARTICLES OBJECTIVE WAS TO REVIEW THE FOLLOWING: AORTIC STENOSIS OR REGURGITATION THAT REQUIRES OPERATIONS IN CHILDREN OFTEN RESULTS FROM UNICUSPID VALVE MORPHOLOGY. IN ALL PAEDIATRIC PATIENTS WITH THIS ANOMALY, WE HAVE PERFORMED UNICUSPID VALVE REPAIR BY BICUSPIDIZATION, CREATING A NEW COMMISSURE VIA ADDING PATCH MATERIAL. THIS STUDY REVIEWED OUR EXPERIENCE WITH THIS PROCEDURE. THE ARTICLE REPORTS THAT PATIENTS WITH A UNICUSPID AORTIC VALVE WHO UNDERWENT BICUSPIDIZATION AT <_18 YEARS OF AGE BETWEEN 2003 AND 2018 WERE EVALUATED. AUTOLOGOUS PERICARDIUM HAD INITIALLY BEEN USED FOR CUSP AUGMENTATION. SINCE 2014, DECELLULARIZED XENOGENEIC TISSUE OR EXPANDED POLYTETRAFLUOROETHYLENE MEMBRANE HAS BEEN APPLIED. THERE WERE 60 CONSECUTIVE PATIENTS WITH GORE¿ PRECLUDE¿ PERICARDIAL MEMBRANE (EXPANDED POLYTETRAFLUOROETHYLENE EPTFE) USED IN 4 PATIENTS. IT WAS REPORTED THAT ONE OUT OF 4 PATIENTS (50%) WITH EPTFE MEMBRANE RE

  Patient problems: Insufficient Information

  MAUDE report 11444264 ↗