BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 9825866 · Received March 12, 2020

    Report

    Report Number
    1625425-2020-00203
    Event Type
    Death
    Date Received
    March 12, 2020
    Date of Event
    July 31, 2017
    Report Date
    March 6, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DOES NOT PROVIDE ANY IDENTIFYING INFORMATION OF THE DEVICE. 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 RE-EVALUATED AS NEEDED.

    Additional Manufacturer Narrative · 1

    5-DAY REPORT, NOT 30-DAY REPORT AS THE INITIAL REPORT STATED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT FILED ON JULY 31, 2019, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2017 BY AN UNKNOWN PHYSICIAN, AT (B)(6) IN (B)(6). THE PATIENT PASSED AWAY ON (B)(6) 2017. THE COMPLAINT ALLEGES THAT THE FILTER HAS CAUSE BREAKTHROUGH PULMONARY EMBOLISM AND DEATH. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290594 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death