BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153308 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04347
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    April 17, 2003
    Report Date
    August 8, 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
    PHYSICIAN

    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. A REVIEW OF COMPLAINTS REPORTED FOR THIS PRODUCT FAMILY FOUND A NEUTRAL TREND FOR THE PERIOD OF MAY 2008 TO JULY 2008.

    Description of Event or Problem · 1

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENT. IT WAS REPORTED THAT APPROX 1 YEAR AND 4 MONTHS POST AN RX WALLSTENT PERMALUME 10MM X 40MM STENT PLACEMENT IN THE DISTAL COMMON BILE DUCT (CBD), IT WAS NOTED THAT THE STENT HAD MIGRATED. THE PT UNDERWENT THE STENT REMOVAL PROCEDURE AT WHICH TIME IT WAS NOTED THAT "40% OF THE STENT WAS VISIBLE IN THE LUMEN." THE STENT WAS REMOVED UTILIZING AN UNSPECIFIED SNARE AND A 2ND RX WALLSTENT PERMALUME 10MM X 40MM STENT WAS PLACED. IT WAS NOTED THAT THE PT'S CONDITION RESOLVED WITH THE STENT REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569700

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention