BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 2155346 · Received June 30, 2011

    Report

    Report Number
    9681442-2011-00036
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA #P070014. THE STENT REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS USER FACILITY REPORT INVOLVES THE SAME PT AS MFR REPORT #9681442-2011-00037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR MONTHS AFTER IMPLANT OF A STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE PT DEVELOPED A HIGH GRADE IN-STENT STENOSIS THAT RESULTED IN CLAUDICATION AND WALKING IMPAIRMENT. PTA SUCCESSFULLY TREATED THE STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUD3067

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention