BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1192133 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02925
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A WALLSTENT WAS IMPLANTED IN THE SHUNT OF THE LEFT ANTEBRACHIAL. AN UNSPECIFIED TIME LATER RESTENOSIS OCCURRED. THE LESION WAS 90% STENOSED WITHOUT CALCIFICATION. THE PHYSICIAN ATTEMPTED TO TREAT THE RESTENOSIS WITH AN 8-4/5.8T/75 ULTRA THIN DIAMOND BALLOON. A NON BSC GUIDE CATHETER WAS INSERTED FROM THE VEIN SIDE AND A NON BSC GUIDE WIRE CROSSED THE LESION BY ANTEROGRADE APPROACH WITHOUT ANY PROBLEMS. THE MIDDLE OF THE LESION TO THE EDGE WAS DILATED AT 10 ATMOSPHERES. THE BALLOON WAS REPOSITIONED AND ON THE SECOND INFLATION THE BALLOON RUPTURED AT 15 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT STATUS IS "NO PROBLEM" WITH NO COMPLICATIONS REPORTED. THE BALLOON RUPTURE 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 ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GC: MOSQUITO 6F| GW TORAY 0.035