BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION IVC FILTER

    MDR report key: 9583210 · Received January 13, 2020

    Report

    Report Number
    1625425-2020-00045
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    February 12, 2016
    Report Date
    December 16, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    PMA / PMN Number
    K133243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DECEMBER 9, 2019, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2016 BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). THE COMPLAINT ALLEGES THAT THE FILTER IS TILTED AND HAS CAUSED PERFORATION. THE COMPLAINT SPECIFICALLY ALLEGES ¿ONE PERFORATED IVC FILTER STRUT CONTACTS THE L2-2 DISC AND THAT PLAINTIFF IS AT INCREASED RISK FOR FUTURE COMPLICATIONS, SUCH AS FILTER FAILURE, PROGRESSIVE PERFORATION, MIGRATION, FRACTURE, EMBOLIZATION, THROMBOSIS, AND DEATH.¿ ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45893 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other