BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 2901957 · Received November 19, 2012

    Report

    Report Number
    9681442-2012-00184
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Report Date
    November 1, 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
    AR, 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, A LOUD POP WAS HEARD AND THE STENT COULD NO LONGER BE DEPLOYED. ANOTHER 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

    Patients

    Seq Age Sex Outcome Treatment
    1