BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1802554 · Received August 9, 2010

    Report

    Report Number
    9681442-2010-00074
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    January 18, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNK. THE STENT REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVAL. 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 APPROX 13 MONTHS POST STENT IMPLANT IN THE SFA, THE PT PRESENTED WITH "SYMPTOMS". AN ANGIOGRAM WAS PERFORMED AND A STENT FRACTURE WAS IDENTIFIED. A STENT GRAFT WAS PLACED INSIDE THE ALLEGED FRACTURED STENT AND FLOW WAS RESTORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention