BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 7818475 · Received August 27, 2018

    Report

    Report Number
    1625425-2018-00130
    Event Type
    Death
    Date Received
    August 27, 2018
    Report Date
    August 27, 2018
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    PMA / PMN Number
    K133243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 AUGUST 15, 2018, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2014 BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6). NO INFORMATION ABOUT ANY ATTEMPTS TO RETRIEVE THE FILTER WERE PROVIDED, THEREFORE IT REMAINS IMPLANTED EITHER FULLY OR PARTIALLY (PROVIDED INFORMATION IS UNCLEAR AS THERE IS A REFERENCE TO THE FILTER ¿NOT COMPLETELY¿ REMOVED).¿ IT IS ALLEGED THAT THE FILTER TILTED, EMBEDDED AND DEATH OCCURRED. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658149 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. Q669772

    Patients

    Seq Age Sex Outcome Treatment
    1 Death