BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABIL BILIARY ENDOPROSTHESIS

    MDR report key: 2973928 · Received February 15, 2013

    Report

    Report Number
    3003910212-2013-00004
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FGE
    PMA / PMN Number
    K081184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GORE VIABIL BILIARY ENDOPROSTHESIS REMAINS IMPLANTED AND THE LOT NUMBER IS NOT AVAILABLE. THEREFORE, A DIRECT PRODUCT ANALYSIS AND REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. THERE ARE MANY COMPLEX CLINICAL VARIABLES, SUCH AS PATIENT CONDITION/HISTORY, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. ALL INFORMATION HAS BEEN MADE AVAILABLE FOR TRACKING AND TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A GORE VIABIL BILIARY ENDOPROSTHESIS WAS PLACED FOR A BENIGN BILIARY STRICTURE. APPROXIMATELY THREE MONTHS POST OPERATIVE, THE PATIENT DEVELOPED CHOLECYSTITIS AND A CHOLECYSTECTOMY WAS PERFORMED. ONE WEEK LATER, THE PATIENT UNDERWENT A ERCP TO PLACE A PLASTIC STENT THROUGH THE GORE VIABIL BILIARY ENDOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69450 GORE VIABIL BILIARY ENDOPROSTHESIS FGE W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention