BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2234011 · Received August 31, 2011

    Report

    Report Number
    2017233-2011-00448
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 30, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF MFG HISTORY. RESULT: DEVICE MET RELEASE SPECS.

    Description of Event or Problem · 1

    TO COMPLETELY BRIDGE THE ANEURYSM IN THE INTERNAL ILIAC ARTERY (HYPOGASTRIC) DURING A AAA TRIFURCATION PROCEDURE, A 13X10 GORE VIABAHN ENDOPROSTHESIS WAS INSERTED BY BRACHIAL ARTERY APPROACH AND ADVANCED THROUGH THE SHEATH TO THE AORTIC ARCH, WHERE THE SHEATH KINKED. THE GORE VIABAHN ENDOPROSTHESIS WAS REMOVED AND THE SHEATH RE-DILATED. THE SAME GORE VIABAHN ENDOPROSTHESIS WAS RE-ADVANCED, SUCCESSFULLY CROSSING THE TRANSITION FROM THE SUBCLAVIAN ARTERY INTO THE AORTIC ARCH. HOWEVER, THE DEVICE WOULD NOT ADVANCE THROUGH THE PREVIOUSLY PLACED 11X5 GORE VIABAHN ENDOPROSTHESIS. THE 13X10 DEVICE WAS PULLED BACK FOR REMOVAL. HOWEVER, BECAUSE OF A KINK IN THE GUIDEWIRE AND CATHETER DAMAGE BY THE GUIDEWIRE, THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE FROM THE BRACHIAL ACCESS SITE. THE PHYSICIAN CUT DOWN THE BRACHIAL ACCESS SITE AND REMOVED THE DEVICE AND SHEATH. ADD'L ACCESS WAS GAINED FROM THE AXILLARY ARTERY, AND A SECOND 13X10 GORE VIABAHN ENDOPROSTHESIS WAS SUCCESSFULLY ADVANCED INTO THE PREVIOUSLY PLACED 11X5 GORE VIABAHN ENDOPROSTHESIS AND DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED IMPLANTING A SURGICAL GRAFT BETWEEN THE BRACHIAL AND AXILLARY ARTERY. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NIP/STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES WLG335 8707163

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention