BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1130933 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-03359
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    May 13, 2004
    Report Date
    July 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
    OTHER

    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 COLD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    WALLSTENT BILIARY REMOVAL CHART REVIEW. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME POST A BILIARY STENT PLACEMENT PROCEDURE, THE PATIENT PRESENTED WITH A "BENIGN DISTAL BILE DUCT STRICTURE" AND UNDERWENT AN ENDOSCOPIC CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP) FOR BIOPSY OF THE STRICTURE AND STENT REMOVAL. DURING REMOVAL OF THE RX WALLSTENT PERMALUME 10MM X 40MM STENT, THE PHYSICIAN NOTED MILD HYPERPLASIA OF THE DISTAL BILIARY DUCT "CONSIDERED [TO BE] RELATED TO THE DEVICE". FOLLOWING STENT REMOVAL, NO FURTHER INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S STATUS IS UNKNOWN, HOWEVER, IT WAS NOTED AT THE PATIENT'S 10-WEEK POST-REMOVAL OF THE STENTS FOLLOW-UP VISIT THE "EVENT [REMAINS] ONGOING".

    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 46 YR Required Intervention