BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1234044 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05923
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL, 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED STENTING PROCEDURE, RESISTANCE WAS ENCOUNTERED AND A SHEATH SEPARATION OCCURRED. THE LOCATION OF THE LESION WAS REPORTED AS "BILIARY." IT WAS NOTED THAT THE PROCEDURE WAS BEING PERFORMED TO TREAT TISSUE INGROWTH OF AN UNSPECIFIED 10MM X 6MM STENT WHICH HAD BEEN PLACED IN A PREVIOUS PROCEDURE. THE RX WALLSTENT 10MM X 80MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. HOWEVER, "SEVERE" RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO DEPLOY THE STENT. UPON CONTINUING TO DEPLOY THE STENT, THE "WHITE PLASTIC PART OF THE OUTER SHEATH" SEPARATED. THE PHYSICIAN WAS ABLE TO RETRACT THE OUTER SHEATH TO SUCCESSFULLY DEPLOY THE STENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC CORPORATION M00569660 11341281

    Patients

    Seq Age Sex Outcome Treatment
    1