BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY STENT W/UNISTEP PLUS

    MDR report key: 1063785 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00774
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING PROCEDURE THE TIP OF THE STENT WAS BENT. THE STENT WAS PARTIALLY DEPLOYED INTO THE COMMON BILE DUCT WHEN THE TIP OF THE STENT WAS BENT. THE PHYSICIAN REMOVED THE DEVICE, AND COMPLETED THE PROCEDURE WITH ANOTHER PRODUCT. THERE WERE NO STENT WIRES PERFORATING THE OUTER SHEATH. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT WAS REPORTED TO BE GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY STENT W/UNISTEP PLUS FGE - BILIARY STENT FGE BOSTON SCIENTIFIC CORPORATION H965430400 11446691

    Patients

    Seq Age Sex Outcome Treatment
    1