BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1811217 · Received August 11, 2010

    Report

    Report Number
    9681442-2010-00077
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 7, 2010
    Report Date
    July 17, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE STENT REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA#P070014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED STENT FORESHORTENED. IT SHOULD BE 12 CM IN LENGTH BUT APPEARS TO BE ONLY 10 CM LONG. AN ADDITIONAL STENT WAS IMPLANTED TO COVER THE LENGTH OF THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANTG3975

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR