BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153305 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04351
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 14, 2004
    Report Date
    August 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
    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 1 YEAR POST AN RX WALLSTENT PERMALUME 10MM X 40MM STENT PLACEMENT IN THE DISTAL COMMON BILE DUCT, THE PT EXPERIENCED RECURRENT OBSTRUCTIVE SYMPTOMS RESULTING FROM A STENT MIGRATION. THE PT UNDERWENT A STENT REMOVAL PROCEDURE AT WHICH TIME IT WAS NOTED THAT THE STENT HAD MIGRATED TO THE DUODENUM. THE STENT WAS REMOVED UTILIZING AN UNSPECIFIED FORCEPS AND A SECOND WALLSTENT PERMALUME 10MM X 60MM STENT WAS PLACED. IT WAS NOTED THAT THE PT'S CONDITION RESOLVED WITH STENT REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569700

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention