BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 2901974 · Received November 19, 2012

    Report

    Report Number
    9681442-2012-00182
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER APPROXIMATELY THREE STRUTS OF A VASCULAR STENT HAD BEEN DEPLOYED IN THE SFA, THE OUTER CATHETER BROKE AND THE DEPLOYMENT TRIGGER BECAME UNRESPONSIVE. AS THE ENTIRE STENT SYSTEM WAS WITHDRAWN, THE PARTIALLY DEPLOYED STENT BECAME STUCK IN THE INTRODUCER SHEATH; THEREFORE, THE SHEATH WAS REMOVED SIMULTANEOUSLY WITH STENT DELIVERY SYSTEM. ANOTHER VASCULAR STENT WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG ANVH0592

    Patients

    Seq Age Sex Outcome Treatment
    1