BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1253110 · Received December 5, 2008

    Report

    Report Number
    3005099803-2008-06971
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    December 15, 2008
    Report Date
    November 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

    DEVICE ANALYSIS: THS 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 THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME PATIENT AS MFR REPORT #3005099803-2008-06667. IT WAS REPORTED IN "RETROSPECTIVE AND PROSPECTIVE CHART REVIEW, AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS", THAT FOLLOWING A BILIARY STENTING TREATMENT PROCEDURE STENT MIGRATION OCCURRED. AN RX WS PERMALUME 10MM X 60MM STENT WAS IMPLANTED TO TREAT A STRICTURE DUE TO NEOPLASIA. THREE DAYS LATER, THE STENT WAS REMOVED DUE TO MIGRATION TO AN UNSPECIFIED LOCATION. THE STENT WAS REPOSITIONED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569710

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other