BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PRECLUDE® PERICARDIAL MEMBRANE

    MDR report key: 14627422 · Received June 7, 2022

    Report

    Report Number
    3007284313-2022-01953
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    September 27, 2020
    Report Date
    June 7, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K012098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FUJITA S, YAMAGISHI M, MIYAZAKI T, MAEDA Y, ITATANI K, YAMAMOTO Y ET AL. LONG-TERM RESULTS OF LARGE-CALIBRE EXPANDED POLYTETRAFLUOROETHYLENE-VALVED CONDUITS WITH BULGING SINUSES. EUR J CARDIOTHORAC SURG 2020;58:1274¿80.

    Description of Event or Problem · 0

    HIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE ¿LONG-TERM RESULTS OF LARGE-CALIBRE EXPANDED POLYTETRAFLUOROETHYLENE-VALVED CONDUITS WITH BULGING SINUSES¿ PUBLISHED IN THE EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 27 SEPTEMBER 2020. THE PURPOSE OF THIS STUDY WAS TO CLARIFY THE LONG-TERM OUTCOMES AND THE DURABILITY OF EPTFE-VALVED CONDUITS. BETWEEN JANUARY 2002 AND DECEMBER 2015, THERE WERE 502 PATIENTS WHO UNDERWENT RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION IN 34 JAPANESE INSTITUTIONS USING EPTFE-VALVED CONDUITS. THE EPTFE TRICUSPID-VALVED CONDUIT IS A HANDMADE VALVED CONDUIT MANUFACTURED THROUGH TWO MAJOR PROCESSES. FIRST, BULGING SINUSES WERE MOLDED ON THE EPTFE GRAFT (STRETCH VASCULAR GRAFT, W.L. GORE & ASSOCIATES, INC., FLAGSTAFF, AZ, USA) AUTOMATICALLY USING A CUSTOM-MADE MACHINE. SECOND, THE FAN-SHAPED VALVES WERE CUT FROM THE 0.1-MM EPTFE MEMBRANE (PRECLUDE PERICARDIAL MEMBRANE, W.L. GORE & ASSOCIATES, INC.) AND SUTURED ON THE LUMEN SIDE OF THE GRAFT BEING TURNED INSIDE OUT. THE DIAMETER OF THE CONDUIT RANGES FROM 6 TO 24 MM, IN 2-MM INCREMENTS, CORRESPONDING TO THE SIZE OF THE EPTFE GRAFT. THE SIZE OF THE CONDUIT WAS SELECTED DEPENDING ON THE PHYSICAL CONSTITUTION AND THE ANATOMICAL FEATURES OF THE HEART. THE ARTICLE REPORTS THAT EIGHT PATIENTS REQUIRED EXPLANTATION OF THE CONDUITS DUE TO STENOSIS OF THE CONDUIT OR SCLEROSIS OF THE VALVE. ONE PATIENT REQUIRED EXPLANTATION OF THE CONDUIT DUE TO REGURGITATION OF THE VALVE. ADDITIONALLY, FOUR PATIENTS REQUIRED CATHETER INTERVENTION TO BALLOON DILATIONS FOR THE STENOSIS OF THE CONDUIT. TWO PATIENTS DEVELOPED INFECTIVE ENDOCARDITIS OF THE CONDUIT AND RECEIVED INTRAVENOUS ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184738 GORE® PRECLUDE® PERICARDIAL MEMBRANE PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention| O