BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2095200 · Received May 10, 2011

    Report

    Report Number
    9681442-2011-00020
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONCLUDED. 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 APPROX THREE MONTHS POST-IMPLANT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE STENT WAS OBSERVED TO BE OCCLUDED. REPORTEDLY, DURING DEPLOYMENT, THERE WAS A SMALL AMOUNT OF MOVEMENT OF THE HANDLE TOWARD THE PT, WHICH RESULTED IN THE STENT BECOMING COMPRESSED. A SECONDARY INTERVENTION OCCURRED TO REVASCULARIZE THE VESSEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention