BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1243023 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06658
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 10, 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

    DEVICE ANALYSIS: 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 HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS THAT FOLLOWING A BILIARY STENTING TREATMENT PROCEDURE IMPACTION, TISSUE OVERGROWN, INGROWTH AND HYPERPLASIA OCCURRED. AN RX WS PERMALUME 10 X 40 MM HAD BEEN ADVANCED TO TREAT A BENIGN STRICTURE IN THE DISTAL COMMON BILE DUCT. THE STENT WAS IMPLANTED WITHOUT COMPLICATIONS. AT AN UNSPECIFIED TIME FOLLOWING STENT IMPLANTATION, THE PT REPORTED PAIN. AT 2 YEARS FOLLOWING IMPLANT, DUE TO IMPACTION, TISSUE INGROWTH AND OVERGROWTH, THE STENT WAS REMOVED. THE TISSUE INGROWTH WAS NOTED TO BE "SERIOUS, MILD AND DEFINITELY RELATED TO THE DEVICE". THE STENT WAS REMOVED UTILIZING BALLOON DILATION AND RAT TOOTH FORCEPS. HYPERPLASIA WAS DISCOVERED. FOLLOWING THE REMOVAL OF THE STENT, THE PHYSICIAN PERFORMED A BALLOON SWEEP EXTRACTION OF STONES WITH AN UNSPECIFIED BALLOON CATHETER. THE PT OUTCOME IS UNK.

    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 37 YR Other| R