BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 2910881 · Received December 3, 2012

    Report

    Report Number
    9681442-2012-00188
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT OCCURRED DURING THE SAME EVENT REFERENCED IN MDR # 99681442-2012-00187.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR STENT SYSTEM KINKED DURING ADVANCEMENT IN THE SFA AND DURING REMOVAL, THE STENT PARTIALLY DEPLOYED WITH THE SAFETY LOCK IN PLACE AND THE STENT FRACTURED. APPROX 2 CM OF THE STENT REMAINED IN THE PT AFTER THE STENT SYSTEM WAS REMOVED AND ANOTHER VASCULAR STENT WAS USED TO TREAT THE LESION AND APPOSE THE DETACHED STENT SEGMENT TO THE VESSEL WALL. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWG1861

    Patients

    Seq Age Sex Outcome Treatment
    1