BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PRECLUDE® PERICARDIAL MEMBRANE

    MDR report key: 18380741 · Received December 22, 2023

    Report

    Report Number
    3007284313-2023-02964
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2023
    Report Date
    April 30, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DXZ
    UDI-DI
    00733132601837
    PMA / PMN Number
    K012098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4 - ADDED DATE H6 - ADDED CODE B01 UPDATED CODE C21 TO C23 UPDATED CODE D16 TO CODES D15, D12, D1103 AND D1001. ENGINEERING EVALUATION: THE IDENTITY OF THE LEAFLET MATERIAL COULD NOT BE DEFINITIVELY CONFIRMED DURING THE EVALUATION. THE ENGINEERING EVALUATION DID NOT IDENTIFY ANY MANUFACTURING DEFICIENCIES RELATED TO THE MANUFACTURE OF THE PRESUMED GORE® PRECLUDE® PERICARDIAL MEMBRANE DEVICE. HOWEVER, OBSERVATIONS OF THE LEAFLETS MADE DURING THE ENGINEERING EVALUATION ARE CONSISTENT WITH THE PHYSICIAN¿S OBSERVATION REGARDING ¿THE STITCHING OF THE SUTURES OF A LEAFLET TEARING.¿ EXPLANT EVALUATION: SPECIMEN 3 HAD THREE FRAGMENTS OF LEAFLETS PRESENT. THE HOLES AND MISSING MATERIAL WERE CONSISTENT WITH THOSE CAUSED BY SUTURE PULL-THROUGH COMBINED WITH CONTINUAL FOLDING OF THE MATERIAL DUE TO REPETITIVE PHYSIOLOGIC MOTION AND/OR THE CONSTRUCTION OF THE DEVICE. THE EXACT TIMING AND CAUSE OF THE HOLES AND MISSING MATERIAL COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE PRESUMED USE OF THE GORE® PRECLUDE® PERICARDIAL MEMBRANE DEVICE AS THE LEAFLETS IN THE VALVE IS OFF-LABEL USE. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE DEVICE IS INDICATED FOR RECONSTRUCTION OR REPAIR OF THE PERICARDIUM PER THE INSTRUCTIONS FOR USE. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE DEVICE IS CONTRAINDICATED FOR USE IN PATIENTS REQUIRING RECONSTRUCTION OF CARDIOVASCULAR DEFECTS SUCH AS CARDIAC, GREAT VESSEL, AND PERIPHERAL VASCULAR. "USE OF THIS PRODUCT IN APPLICATIONS OTHER THAN THOSE INDICATED HAS THE POTENTIAL FOR SERIOUS COMPLICATIONS, SUCH AS SUTURE PULLOUT OR FAILURE OF THE REPAIR (ANEURYSM FORMATION).¿ B3 - ADDED CORRECTED INFORMATION TO EVENT DESCRIPTION H6 - CHANGED CODE E062101 TO E062103.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    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 REPORTED ON DECEMBER 7, 2023, THAT THE PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: "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: (B)(6) 2017 - AORTIC VALVE REPAIR (B)(6) 2017 - PATIENT DEVELOPED SEVERE AORTIC INSUFFICIENCY AFTER VALVE REPAIR (B)(6) 2017. TAKEN BACK TO OPERATING ROOM FOR A ROSS PROCEDURE USING A GORE® PRECLUDE® PERICARDIAL MEMBRANE AND A GORE-TEX® STRETCH VASCULAR GRAFT. THE PATIENT PRESENTED IN (B)(6) 2022 WITH AORTIC INSUFFICIENCY AND STENOSIS OF THE CONDUIT. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE AND A GORE-TEX® STRETCH VASCULAR GRAFT WERE EXPLANTED ON (B)(6) 2022. ADDITIONAL NOTE: IT WAS REPORTED ON DECEMBER 7, 2023 THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278992 GORE® PRECLUDE® PERICARDIAL MEMBRANE PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES, INC. 00733132601837

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Hospitalization| R