BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1143703 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04153
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 6, 2005
    Report Date
    August 1, 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 EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT 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 APPROXIMATELY 8 DAYS POST AN RX WALLSTENT PERMALUME 10MM X 80MM STENT PLACEMENT "ACROSS AN ANASTOMOSIS STENOSIS" IN AN UNSPECIFIED LOCATION, THE STENT WAS REMOVED FOR UNSPECIFIED REASONS. DURING REMOVAL, INTIMAL HYPERPLASIA WAS NOTED ON THE COVERED PORTION OF THE STENT. THE PT HAD AN UNKNOWN ETIOLOGY FOR ELEVATED LIVER FUNCTION TESTS (LFT'S), HOWEVER, THERE WAS NO EVIDENCE OF BILIARY OBSTRUCTION. NO FURTHER INTERVENTION WAS PERFORMED THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention