BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1253244 · Received December 5, 2008

    Report

    Report Number
    3005099803-2008-06980
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    December 27, 2005
    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: THIS 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

    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 MALIGNANT STRICTURE IN THE DISTAL COMMON BILE DUCT. AT AN UNSPECIFIED TIME LATER, THE PATIENT EXPERIENCED JAUNDICE. THE PATIENT WAS EVALUATED 6 MONTHS FOLLOWING STENT IMPLANT, AND IT WAS DISCOVERED THAT THE PREVIOUSLY IMPLANTED STENT HAD MIGRATED FROM ITS IMPLANT LOCATION TO THE DUODENUM. THE STENT WAS REMOVED WITH NO TECHNICAL DIFFICULTIES. A 10X80MM COVERED STENT WAS IMPLANTED. THERE HAVE BEEN 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 69 YR Other