BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2151567 · Received June 29, 2011

    Report

    Report Number
    2017233-2011-00317
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 27, 2011
    Manufacturer
    W.L. GORE & ASSOCAITES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, TWO GORE VIABAHN ENDOPROSTHESIS WERE USED TO TREAT A RIGHT COMMON ILIAC ARTERY ANEURYSM USING THE (B)(6) TECHNIQUE TO PRESERVE FLOW INTO THE HYPOGASTRIC ARTERY. THE FIRST DEVICE WAS ADVANCED VIA IPSILATERAL FEMORAL ACCESS AND DEPLOYED EXTENDING INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE SECOND DEVICE WAS DEPLOYED TRANSTRACHEALLY EXTENDING INTO THE RIGHT HYPOGASTRIC ARTERY. DEVICE PLACEMENT WAS REPORTED TO BE PERFECT WITH GOOD FLOW TO THE EXTERNAL ILIAC ARTERY AND HYPOGASTRIC ARTERY. ON (B)(6) 2011, AN AORTOGRAM REVEALED NO FLOW INTO THE RIGHT EXTERNAL ILIAC ARTERY WITH FLOW NOTED INTO THE HYPOGASTRIC ARTERY. AN ATTEMPT TO BALLOON THE COLLAPSED GRAFT WAS UNSUCCESSFUL USING A 10MM PTA BALLOON. TWO SELF-EXPANDING BARE METAL STENTS WERE DEPLOYED INTO THE COLLAPSED VIABAHN DEVICE. BOTH BARE METAL STENTS WERE BALLOONED. COMPLETION ANGIO REVEALED GOOD FLOW INTO THE EXTERNAL ILIAC ARTERY. THE PT TOLERATED PROCEDURE 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 & ASSOCAITES WLG335 8502844

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention