BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1966274 · Received January 14, 2011

    Report

    Report Number
    2017233-2011-00021
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 22, 2010
    Report Date
    January 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ON (B)(4) 2010, WE RECEIVED ADD'L EVENT INFO INCLUDING ADD'L DEVICES USED IN THE PROCEDURE. SIX DEVICES WERE IMPLANTED. THE LOCATION OF THE IMPLANTED DEVICES (LEFT OR RIGHT LEG) WAS NOT UNAVAILABLE. THEREFORE, ADD'L MEDWATCHES WERE REPORTED FOR THIS EVENT. MFR REPORT#2017233-2011-00017 LOT # 8028596; MFR REPORT #2017233-2010-00549 LOT # 8028600; MFR REPORT #2017233-2011-00020 LOT # 8110409; MFR REPORT #2017233-2011-00019 LOT # 8100904; MFR REPORT #2017233-2011-00023 LOT # 8191576.

    Description of Event or Problem · 1

    SIX GORE VIABAHN ENDOPROSTHESIS WERE IMPLANTED IN THE BILATERAL SUPERFICIAL FEMORAL ARTERIES ON SUCCESSIVE DAYS ((B)(6) 2010). ON (B)(6) 2010, THE PT PRESENTED WITH RECURRING CLAUDICATION IN THE RIGHT LEG. THE VIABAHN DEVICES WERE OCCLUDED AND A THROMBECTOMY WAS PERFORMED. THE PT THEN PRESENTED WITH SYMPTOMS OF LEFT LEG COMPROMISED BLOOD FLOW. THE THROMBOSIS AND DECLOT IN THE LEFT LEG WAS PERFORMED. HEPARIN-INDUCED THROMBOCYTOPENIA WAS SUSPECTED AND LATER CONFIRMED DUE TO THROMBOTIC EVENTS. ALL OF THE VIABAHN DEVICES REMAINED IMPLANTED.

    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 8191575

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention