BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 2760621 · Received September 19, 2012

    Report

    Report Number
    9681442-2012-00146
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 31, 2012
    Report Date
    August 31, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VASCULAR STENT IN THE SFA, THE STENT DEPLOYED 1 MM AND THEN COULD NO LONGER BE DEPLOYED. THE ENTIRE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND ANOTHER VASCULAR STENT WAS SUCCESSFULLY PLACED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1