BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153302 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04345
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    May 13, 2004
    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.

    Description of Event or Problem · 1

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT APPROX 3 WEEKS POST AN RX WALLSTENT PERMALUME 10MM X 40MM STENT PLACEMENT IN THE DISTAL COMMON BILE DUCT (CBD), THE PT UNDERWENT A PLANNED STRICTURE REVISION PROCEDURE AT WHICH TIME THE STENT WAS REMOVED. DURING REMOVAL, THE PHYSICIAN NOTED HYPERPLASIA. IT WAS NOTED THAT THE EVENT WAS NOT SERIOUS, MILD IN SEVERITY, AND "DEFINITELY RELATED" TO THE DEVICE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PT'S CURRENT CARE IS REPORTED AS "ONGOING".

    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 46 YR Required Intervention