BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3162496 · Received June 6, 2013

    Report

    Report Number
    9681442-2013-00056
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENT PROCEDURE IN THE SFA, THE VASCULAR STENT PROCEDURE IN THE SFA, THE VASCULAR STENT DEPLOYED APPROXIMATELY 1 CM; HOWEVER, THE VASCULAR STENT COULD NOT BE COMPLETELY DEPLOYED. THE PARTIALLY DEPLOYED VASCULAR STENT AND DELIVERY SYSTEM WERE EXCHANGED OVER THE WIRE FOR A NEW VASCULAR STENT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251787 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXC0063

    Patients

    Seq Age Sex Outcome Treatment
    1