BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 6474431 · Received April 8, 2017

    Report

    Report Number
    1625425-2017-00053
    Event Type
    Death
    Date Received
    April 8, 2017
    Report Date
    April 7, 2017
    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
    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. PULMONARY EMBOLISM IS ONE OF THE POTENTIAL COMPLICATIONS CITED IN THE IFU ASSOCIATED WITH THIS PRODUCT. THERE ARE NO INDICATIONS THAT THE DEVICE MALFUNCTIONED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT FILED ON MARCH 14, 2017, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2014. APPROXIMATELY 18 MONTHS LATER THE PATIENT ALLEGEDLY SUFFERED A MASSIVE PULMONARY EMBOLISM AND DIED. THE PATIENT DIED WITH THE FILTER IN PLACE. (B)(4) ATTORNEYS ARE ATTEMPTING TO GATHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256356 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death