BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1153354 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04349
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    May 6, 2004
    Report Date
    August 8, 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 COULD NOT BE COMPLETED. A REVIEW OF THE COMPLAINTS REPORTED FOR THIS PRODUCT FAMILY FOUND A NEUTRAL TREND FOR THE PERIOD OF 2008.

    Description of Event or Problem · 1

    RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS. IT WAS REPORTED THAT 1 YEAR POST AN RX WALLSTENT PERMALUME 10MM X 40MM STENT PLACED IN THE DISTAL COMMON BILE DUCT (CBD), THE PATIENT UNDERWENT A PLANNED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP) WITH STENT REMOVAL FOR STRICTURE REVISION. IT WAS NOTED THAT NO COMPLICATIONS HAD OCCURRED DURING THE INITIAL STENT PLACEMENT PROCEDURE. UPON REMOVAL, HYPERPLASIA WAS NOTED AT THE DISTAL END OF THE STENT. THE EVENT WAS MILD, NOT SERIOUS, AND DEFINITELY RELATED TO THE DEVICE. UNSPECIFIED TECHNICAL DIFFICULTIES WERE ALSO NOTED DURING STENT REMOVAL AND THE STENT FRACTURED WITH REMNANT FIBERS REMAINING INSIDE THE PATIENT. FOLLOWING STENT REMOVAL, A PANCREATIC STONE EXTRACTION WAS PERFORMED BY UNSPECIFIED MEANS. THE PATIENT'S HYPERPLASIA WAS NOTED AS "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 48 YR Required Intervention