BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCLUAR STENT SYSTEM

    MDR report key: 2841367 · Received October 23, 2012

    Report

    Report Number
    9681442-2012-00165
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION SI CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR STENT PREMATURELY DEPLOYED IN THE ILIAC/COMMON FEMORAL ARTERY DURING ADVANCEMENT TO THE TREATMENT SITE IN THE SFA. THE STENT REMAINS IMPLANTED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT SOLO VASCLUAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVJ1379

    Patients

    Seq Age Sex Outcome Treatment
    1