BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1070475 · Received July 7, 2008

    Report

    Report Number
    3005099803-2008-01066
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    911292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING TREATMENT PROCEDURE, THE STENT FAILED TO DEPLOY. AN 8FR 10X80MM 194CM WALLSTENT BILIARY STENT HAD BEEN SELECTED AND ADVANCED TO TREAT AN UNSPECIFIED LESION. THE PHYSICIAN WAS UNABLE TO DEPLOY THE DEVICE IN ITS INTENDED LOCATION AS THE STENT "COULDN'T BE OPENED". THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO INJURY TO THE PATIENT REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC H965431200 8720911

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR