BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1193252 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05089
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, THE STENT FAILED TO DEPLOY. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). THE RX WALLSTENT PERMALUME 10 MM X 80 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY AND IT WAS THOUGHT THAT THE SHAFT MAY HAVE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720 0011498924

    Patients

    Seq Age Sex Outcome Treatment
    1