BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 6876727 · Received September 19, 2017

    Report

    Report Number
    1625425-2017-00130
    Event Type
    Death
    Date Received
    September 19, 2017
    Date of Event
    September 16, 2015
    Report Date
    September 19, 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.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT FILED ON (B)(6)HE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) BY DR. (B)(6) AT (B)(6). THE PATIENT DIED APPROXIMATELY 3 WEEKS LATER, ON OR ABOUT (B)(6) 2015 DUE TO BUT NOT LIMITED TO ¿CARDIOPULMONARY ARREST RESULTING FROM BILATERAL PULMONARY THROMBOEMBOLI WHICH COMPLETELY OCCLUDED THE MAIN, RIGHT, AND LEFT PULMONARY ARTERIES.¿ FURTHER IT IS ALLEGED THAT ¿AN AUTOPSY REVEALED THE FILTER ¿HAD FAILED TO FILTER OR CATCH BLOOD CLOTS/THROMBI TRAVELING TO DECEDENT¿S HEART AND LUNGS.¿ ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656813 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death