BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1051821 · Received May 13, 2008

    Report

    Report Number
    2017233-2008-00190
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 12, 2008
    Report Date
    May 12, 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

    A SECOND VIABAHN DEVICE WAS ALSO INVOLVED IN THIS EVENT. D4: MODEL # WLG335; LOT # 05579303; CATALOG#: VBH061002; EXPIRATION DATE: 11/30/2010; DEVICE MFR DATE: 12/2007. THE DEVICES REMAIN IN THE PT AND ARE CURRENTLY FUNCTIONAL. A REVIEW OF THE MFG RECORDS FOR BOTH LOTS WAS CONDUCTED. THE REVIEW OF THE MFG RECORDS VERIFIED THAT BOTH LOTS WERE PROCESSED NORMALLY AND PRE-RELEASE SPECIFICATIONS WERE MET.

    Description of Event or Problem · 1

    IN 2008, THE PT PRESENTED WITH AN OCCLUSION OF THE RIGHT SUPERIOR FEMORAL ARTERY AND WAS TREATED WITH TWO VIABAHN ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE. POST ANGIOGRAPHIC IMAGES DEMONSTRATED A PATENT SUPERIOR FEMORAL ARTERY WITH 3-VESSEL RUN-OFF. ON THE FOLLOWING MONTH, AN OCCLUSION WAS FOUND PROXIMAL TO THE ENDOPROSTHESES AND THE PT WAS TREATED WITH INTRAVENOUS RETAVASE. RESOLUTION OF THE OCCLUSION WAS DEMONSTRATED POST-PROCEDURALLY WITH TWO-VESSEL RUN-OFF. TWENTY-FOUR HOURS LATER, THE PT WAS NOTED TO HAVE ANTERIOR AND POSTERIOR TIBIAL THROMBUS AT THE LEVEL OF THE ANKLE AND FOOT WHICH REQUIRED ADD'L THROMBOLYTIC THERAPY. THE FOLLOWING DAY, ANGIOGRAPHY REVEALED WIDELY PATENT STENT-GRAFTS AS WELL AS PATENT SUPERIOR FEMORAL, ANTERIOR AND POSTERIOR TIBIAL ARTERIES. THE PHYSICIAN STATED THAT THE PT WAS NOT TAKING HIS ANTI-PLATELET MEDICINE (PLAVIX), THUS NOT ADHERING TO THE PRESCRIBED PROTOCOL. ACCORDING TO THE PHYSICIAN, THE OCCLUSION WAS THE RESULT OF NON-COMPLIANCE OF THE PT IN TAKING HIS ANTI-PLATELET THERAPY, AND NOT DEVICE-RELATED. THE PT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335 05639336

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention