BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2068404 · Received April 13, 2011

    Report

    Report Number
    9681442-2011-00013
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 30, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE STENT 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 SIX MONTHS POST-IMPLANT, THE VASCULAR STENT WAS FOUND TO BE FRACTURED. REPORTEDLY, THE PATIENT PRESENTED WITH LEG PAIN AFTER RIGOROUS EXERCISE AND AN ULTRASOUND CONFIRMED A STENT FRACTURE. ANGIOPLASTY WAS PERFORMED AND ANOTHER STENT WAS IMPLANTED, RELINING THE FRACTURED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANTJ1762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention