BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1231066 · Received October 30, 2008

    Report

    Report Number
    3005099803-2008-05528
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE STENT APPEARED "TOO LONG". A MODEL CVD BIL ENDO 8FR 10X80 194CM STENT HAD BEEN ADVANCED INSIDE A PREVIOUSLY IMPLANTED STENT IN THE COMMON BILE DUCT. THE STENT WAS DEPLOYED AND IT APPEARED THAT THE STENT WAS "TOO LONG". THE STENT WAS EXPLANTED AND MEASURED TO BE 9CM NOT 8CM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 BOSTON SCIENTIFIC H965431200 11112485

    Patients

    Seq Age Sex Outcome Treatment
    1