BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1941764 · Received December 22, 2010

    Report

    Report Number
    2017233-2010-00574
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    December 21, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - BASED ON THE EVENT DESCRIPTION, THE UNINTENTIONAL PLACEMENT OF THE DEVICES WITH A 4MM GAP BETWEEN THE DEVICES MAY HAVE CONTRIBUTED TO THE STENOSIS AND SUBSEQUENT REINTERVENTION. NOTE: THIS EVENT INVOLVES TWO DEVICES. MFR REPORT #2017233-2010-00573 CAPTURED THE 5MM DEVICE (LOT#06477802A).

    Description of Event or Problem · 1

    ON (B)(6) 2010, TWO GORE VIABAHN ENDOPROSTHESES WERE IMPLANTED FOR THE TREATMENT OF SUPERFICIAL FEMORAL ARTERY DISEASE. DURING THE POSITIONING OF THE DEVICES, THE DEVICES WERE NOT OVERLAPPED AND WERE UNINTENTIONALLY DEPLOYED WITH A 4MM GAP BETWEEN THE DEVICES. STENOSIS LATER DEVELOPED IN THE 4MM GAP, AT THE PROXIMAL EDGE OF THE DISTALLY IMPLANTED 5MM DEVICE AND IN THE PROXIMAL PORTION OF THE PROXIMALLY PLACED 6MM DEVICE. ON (B)(6) 2010, A PTA WAS PERFORMED TO TREAT ALL STENOTIC AREAS.

    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 06508048

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention