BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1230219 · Received November 13, 2008

    Report

    Report Number
    3005099803-2008-06475
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    July 14, 2005
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    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 THE BATCH HISTORY, 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

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT 885 DAYS FOLLOWING PLACEMENT OF A WALLSTENT, THE DEVICE WAS REMOVED DUE TO PATIENT COMPLICATIONS. THE PATIENT INITIALLY HAD A COVERED WALLSTENT PLACED TO MANAGE A STRICTURE. THE WALLSTENT WAS REMOVED 885 DAYS FOLLOWING THE IMPLANT PROCEDURE. DURING THE REMOVAL PROCEDURE, IT WAS NOTED THAT THE STENT WAS IMPACTED WITH STONES IN THE DISTAL COMMON BILE DUCT. THERE WAS ALSO BILIARY SEPSIS. THE WALLSTENT WAS REMOVED WITH A SNARE AND A BALLOON EXTRACTION OF THE STONES WAS PERFORMED POST STENT REMOVAL WITH NO FURTHER PATIENT COMPLICATIONS. THE INVESTIGATOR ASSESSED THE EVENT SERIOUS, MILD IN SEVERITY, DEFINITIVELY RELATED TO THE DEVICE, AND UNRELATED TO THE PROCEDURE.

    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 73 YR