BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT

    MDR report key: 2064387 · Received April 5, 2011

    Report

    Report Number
    9681442-2011-00012
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO PMA #P070014 MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST-IMPLANT IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT WAS FOUND TO BE FRACTURED. REPORTEDLY, THE PATIENT PRESENTED WITH RIGHT CALF PAIN AND A FOLLOW-UP PROCEDURE IDENTIFIED STENT FRACTURES AND IN-STENT STENOSIS. ANGIOPLASTY WITH A PTA BALLOON WAS PERFORMED AND ANOTHER STENT WAS IMPLANTED WITH GOOD RESULTS AND RESTORED FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK 58583125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention