BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY STENT SYSTEM

    MDR report key: 2123037 · Received October 3, 2007

    Report

    Report Number
    MW5020953
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    August 14, 2007
    Report Date
    October 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT ILIAC ANGIOPLASTY A STENT DEPLOYED. STENT WAS NOTED TO BE LOCATED IN THE RIGHT ILIAC ARTERY UP AGAINST THE WALL OF THE ARTERY. STENT SYSTEM WAS 7MM X 37 MM 75 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY STENT SYSTEM ANGIOPLASTY ILIAC ARTERY STENT DEVICE FGE BOSTON SCIENTIFIC 38046 8485814

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention