BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT

    MDR report key: 1132613 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02425
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WAS APPARENTLY DISCARDED BY THE FACILITY, THEREFORE NO DIRECT PROD ANALYSIS WILL BE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTA, A BALLOON RUPTURE OCCURRED. THE BALLOON RUPTURE OCCURED DURING A PROCEDURE TO TREAT AN INSTENT RESTENOSIS OF A WALLSTENT THAT HAD BEEN PREVIOUSLY IMPLANTED IN THE ANTEBRACHIAL VEIN. THE PHYSICIAN ATTEMPTED TO TREAT THE RESTENOSIS WITH A SYMMETRY 5.0-20/4T/90 BALLOON, HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ADD'L INFO REGARDING THE IMPLANT OF THE WALLSTENT HAS BEEN REQUESTED. THE BALLOON RUPTURED REFERENCED WILL BE REPORTED ON THE 3RD QUARTER ALTERNATIVE SUMMARY REPORT FROM BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT NONE FGE BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention