BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1221995 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06105
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    July 11, 2005
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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 EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AN SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THE 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 POST AN INDWELL PROCEDURE, PT COMPLICATIONS OCCURRED. IN 2005, THE PT PRESENTED WITH A HISTORY OF CHOLEDOCHOLITHIASIS STATUS POST CHOLECYSTECTOMY, PERIAMPULLARY DIVERTICULUM AND A BENIGN STRICTURE DUE TO BILE DUCT INJURY. A 10 X 60 PERMALUME WALLSTENT WAS PLACED IN THE DISTAL COMMON BILE DUCT FOR MGMT OF THE STRICTURE. ABOUT 10 WEEKS LATER, THE PT PRESENTED WITH COMPLAINTS OF CONTINUOUS DISCOMFORT FOLLOWING STENT PLACEMENT, WHICH SHE ATTRIBUTED TO THE WALLSTENT. THE WALLSTENT WAS REMOVED WITH NO COMPLICATIONS. NO FURTHER PT COMPLICATIONS WERE REPORTED. THE EVENT WAS RESOLVED WITH REMOVAL OF STENT.

    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 59 YR Required Intervention