BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1180177 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04929
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 21, 2004
    Report Date
    September 3, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE "RETROSPECTIVE AND PROSPECTIVE CHART REVIEW AND ANALYSIS OF ENDOSCOPIC TREATMENT BY BILIARY STENTS" STUDY THAT APPROXIMATELY 4 MONTHS POST AN RX WALLSTENT PERMALUME 10MM X 40MM STENT PLACEMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE STENT HAD BEEN PLACED IN THE DISTAL COMMON BILE DUCT (CBD) FOR A BENIGN BILIARY STRICTURE. DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN ENCOUNTERED "TECHNICAL DIFFICULTIES" AS THE STENT WAS FOUND TO BE IMBEDDED IN THE CBD. THE STENT WAS ABLE TO BE REMOVED WITH "BALLOON DILATION AND RAT TOOTH FORCEPS". NO PATIENT COMPLICATIONS WERE REPORTED. TWO DAYS LATER, A BILE DUCT PERFORATION WAS NOTED THAT WAS FELT TO BE RELATED TO A "MALPOSITIONED DILATING BALLOON" THAT WAS PLACED ABOVE THE METAL WS THAT RESULTED IN A SUDDEN RUPTURE. AN UNKNOWN PLASTIC STENT WAS PLACED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    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 32 YR Other| R