BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153356 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04341
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    November 17, 2003
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT AT UNSPECIFIED TIME POST AN RX WALLSTENT PERMALUME 10MM X 80MM STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED A GALLBLADDER FOSSA ABSCESS AND RECURRENT OBSTRUCTIVE SYMPTOMS. THE PATIENT UNDERWENT A STENT REMOVAL PROCEDURE AT WHICH TIME THE STENT WAS REMOVED UTILIZING AN UNSPECIFIED SNARE AND EXTRACTION BALLOON. ANOTHER RX WALLSTENT PERMALUME 10MM X 80MM STENT WAS PLACED. IT WAS NOTED THAT THE PATIENT'S CONDITION RESOLVED 1 MONTH LATER FOLLOWING EXTERNAL ULTRASOUND (EUS) GUIDED DRAINAGE OF THE GALLBLADDER FOSSA COLLECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R