BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGON OPTION IVC FILTER

    MDR report key: 3042728 · Received April 3, 2013

    Report

    Report Number
    MW5029647
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ARGON MEDICAL DEVICES INC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF A LEG OF AN INFERIOR VENA CAVA FILTER (IVC FILTER). THE LEG PENETRATED THE WALL OF THE IVC AND NOW SITS BETWEEN THE IVC AND THE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136347 ARGON OPTION IVC FILTER OPTION IVC FILTER DTK ARGON MEDICAL DEVICES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR