BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1653710 · Received March 29, 2010

    Report

    Report Number
    9681442-2010-00021
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Report Date
    March 1, 2010
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN. THE STENT REMAINS IMPLANTED; THEREFORE, 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 IMAGING TAKEN APPROXIMATELY NINE MONTHS POST STENT IMPLANT IN THE DISTAL SFA, SHOWED A DEFORMED STENT WITH HIGH DEGREE PROXIMAL IN-STENT RE-STENOSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1