BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1241074 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06587
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    December 6, 2005
    Report Date
    October 24, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFO 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 APPROX 3 MONTHS POST PLACEMENT OF A 10 MM X 60 MM RX WALLSTENT PERMALUME STENT ACROSS THE AMPULLA FOR MGMT OF A STRICTURE, THE PT UNDERWENT A SCHEDULED STRICTURE REVISION. DURING THE PROCEDURE, TISSUE OVERGROWTH WAS NOTED. THE PHYSICIAN ASSESSED THE EVENT AS MILD, SERIOUS, AND DEFINITELY RELATED TO THE DEVICE. THE STENT WAS REMOVED WITH BALLOON DILATION AND A RAT TOOTH FORCEPS. NO FURTHER INTERVENTION WAS PERFORMED. IT WAS NOTED THAT THE PT'S CONDITION RESOLVED FOLLOWING STENT REMOVAL.

    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 79 YR Required Intervention