BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 4092193 · Received August 20, 2014

    Report

    Report Number
    9681442-2014-00116
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT FAILED TO DEPLOY AND A FRAGMENT OF THE STENT REMAINED IN THE VESSEL. NO ADDITIONAL VASCULAR STENTING PROCEDURES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500764 LIFESTENT VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXD3563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention