BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153311 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04343
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    February 1, 2006
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    SAME PT AS MFR REPORT # 3005099803-2008-04342. RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILARY STENTS. IT WAS REPORTED THAT APPROX 3 YEARS POST AN RX WALLSTENT PERMALUME 10MM X 40MM, IT WAS NOTED THAT THE STENT HAD MIGRATED. IT WAS NOT KNOWN IF THE STENT HAD BEEN REMOVED. THE PT'S STATUS IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention