GORE PRECLUDE Pericardial Membrane 1PCM001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132601806), received between Dec 2, 2019 and Dec 2, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Calcified” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2019Calcified; Off-Label Use; Calcified; Off-Label Use

  IT WAS REPORTED A PATIENT UNDERWENT TRUNCUS ARTERIOSUS REPAIR ON (B)(6) 2009 WHERE A 12MM GORE MASA VALVE WAS PLACED. THE PATIENT THEN UNDERWENT A RV-PA CONDUIT REPLACEMENT ON (B)(6) 2015 WHERE AN 18MM GORE TRI-LEAFLET CONDUIT WAS PLACED. THE PATIENT HAD DONE WELL SINCE THE PREVIOUS SURGERY. THE PATIENT HAD A RECENT ECHOCARDIOGRAM PERFORMED THAT SHOWED AN INCREASED CONDUIT GRADIENT AND WAS REFERRED TO CARDIAC CATHETERIZATION FOR PLACEMENT OF A MELODY VALVE. THE VALVE WAS NOT PLACED IN THE CATH LAB DUE TO A MASS ON THE CURRENT 18MM GORE CONDUIT. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE (WHICH WERE THE LEAFLETS OF THE MASA VALVE CONDUIT) HAD MULTIPLE CALCIFICATIONS PRESENT. THESE CALCIFICATIONS WERE WORRISOME FOR ENDOCARDITIS, THUS PRECLUDING PLACEMENT OF A MELODY VALVE AND REQUIRING SURGICAL REPLACEMENT OF THE RV-PA CONDUIT ON (B)(6) 2019 WITH A NEW 24MM TRI-LEAFLET CONDUIT. CULTURES AND INFLAMMATORY LABS WERE NEGATIVE. UPON EXPLANT OF THE 18MM GORE TRI-LEAFLET CONDUIT THE PHYSICIAN NOTED THAT THERE WAS NARROWING AT THE LEVEL OF THE TRI-LEAFLET VALVE. THERE WERE SOME CALCIFICATIONS AT THE LEVEL OF THE VALVE LEAFLETS ON THE LEADING EDGES THAT ARE SUGGESTIVE OF PRIOR ENDOCARDITIS.

  Patient problems: Calcium Deposits/Calcification; Stenosis

  MAUDE report 9398808 ↗