BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 7660279 · Received July 3, 2018

    Report

    Report Number
    1625425-2018-00073
    Event Type
    Death
    Date Received
    July 3, 2018
    Date of Event
    August 21, 2017
    Report Date
    July 3, 2018
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    PMA / PMN Number
    K133243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND NO IMAGES OR VIDEOS HAVE BEEN PROVIDED OF THE FILTER IN-VIVO, SO THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, THIS ISSUE WILL BE REEVALUATED AS NEEDED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT FILED ON MAY 29, 2018, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2017 BY AN UNKNOWN PHYSICIAN AT M.D. (B)(6). ALLEGEDLY, 6 DAYS LATER, ON OR ABOUT (B)(6) 2017, THE FILTER HAD ALLEGEDLY MIGRATED FROM THE POSITION IN THE VENA CAVA AT THE BIFURCATION OF THE ILIAC VEINS AND THE PATIENT HAD TO UNDERGO EMERGENCY CARDIAC SURGERY TO REMOVE THE FILTER. THE PATIENT DIED 3 DAYS LATER, ON OR ABOUT (B)(6) 2017 DUE TO CARDIAC ARREST. (B)(6) ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503528 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death