BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1063367 · Received June 19, 2008

    Report

    Report Number
    2017233-2008-00337
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 11, 2008
    Report Date
    June 19, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL LOT NUMBERS WERE NOT REPORTED FOR THIS EVENT. CONSEQUENTLY, A REVIEW OF THE MFG PAPERWORK FOR EACH LOT COULD NOT BE PERFORMED. THE TRANSITION FROM DISTAL DEVICE TO ARTERY AND THE QUALITY OF THE DISTAL VESSEL RUNOFF MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DURING THE TREATMENT OF SFA, THREE GORE VIABAHN ENDOPROSTHESIS WERE USED TO TREAT RE-STENOSIS OF BARE METAL STENTS. WHEN THE PHYSICIAN RELINED THE BARE STENTS, THE DEVICES WERE EXTENDED DISTALLY TO ABOUT 2 CM ABOVE THE KNEE JOINT. REPORTEDLY, THE TRANSITION FROM DEVICE TO ARTERY WAS APPROX 2 MM (6 MM DEVICE INTO A 4 MM VESSEL). THE PT REPORTEDLY HAD ONE DISEASED VESSEL RUNOFF. APPROX 28-29 DAYS POST PROCEDURE, ALL THREE DEVICES THROMBOSED. THE PT UNDERWENT A SAPHENOUS VEIN GRAFT BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention