BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® VASCULAR GRAFT

    MDR report key: 14776865 · Received June 22, 2022

    Report

    Report Number
    2017233-2022-03035
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    September 27, 2020
    Report Date
    June 22, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: FUJITA S, YAMAGISHI M, MIYAZAKI T, MAEDA Y, ITATANI K, YAMAMOTO Y ET AL. LONG-TERM RESULTS OF LARGE-CALIBRE EXPANDED POLYTETRAFLUOROETHYLENEVALVED CONDUITS WITH BULGING SINUSES. EUR J CARDIOTHORAC SURG 2020;58:1274¿80. DEVICE INFORMATION, PATIENT INFORMATION, AND CASE DETAILS WERE REQUESTED FROM THE CORRESPONDING AUTHOR; HOWEVER, TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    THIS 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 18 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 TWO PATIENTS DEVELOPED INFECTIVE ENDOCARDITIS OF THE CONDUIT AND RECEIVED INTRAVENOUS ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811722 GORE-TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention