BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2122981 · Received June 10, 2011

    Report

    Report Number
    2017233-2011-00275
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 10, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, DURING A PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, THE ILIAC ARTERY TORE. IT WAS REPORTED TO GORE THAT THE PHYSICIAN IMPLANTED A GORE VIABAHN ENDOPROSTHESIS AND AN ILIAC EXTENDER COMPONENT TO SEAL THE TEAR BUT WAS UNSUCCESSFUL. BOTH DEVICES WERE SURGICALLY REMOVED, THE ILIAC ARTERY WAS SUTURED AND THE PATIENT WAS FINE.

    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 8112934

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ILIAC EXTENDER COMPONENT