BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2801460 · Received October 10, 2012

    Report

    Report Number
    2017233-2012-00704
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    January 27, 2012
    Report Date
    September 10, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE STERILIZATION RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. REVIEW OF THE MFG RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS.

    Description of Event or Problem · 1

    PT PRESENTED WITH CALCIFIED STENOSIS IN THE RIGHT POPLITEAL ARTERY. A GORE VIABAHN ENDOPROSTHESIS WAS IMPLANTED (B)(6) 2011. CT SCAN (B)(6) 2012 REVEALED A 'DOTTED AREA' IN THE HOLLOW OF THE KNEE. EXPLORATORY SURGERY REVEALED MORPHOLOGICAL DAMAGE TO AN ARTERIAL SEGMENT. THE GORE VIABAHN ENDOPROSTHESIS WAS EXPLANTED.

    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 8744779

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention