BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTION IVC FILTER

    MDR report key: 6332184 · Received February 15, 2017

    Report

    Report Number
    1625425-2017-00018
    Event Type
    Death
    Date Received
    February 15, 2017
    Date of Event
    November 25, 2015
    Report Date
    February 15, 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 (B)(6) 2016, THE PATIENT PRESCRIBED AND IMPLANTED AN OPTION ELITE RETRIEVABLE IVC FILTER, ON OR ABOUT (B)(6) 2013 BY DR. (B)(6) HOSPITAL. THE PLAINTIFF ALLEGED THE PATIENT DIED AS RESULT OF A DEFECTIVE FILTER APPROXIMATELY 2 YEARS AFTER IMPLANT, ON (B)(6) 2015 AT (B)(6) HOSPITAL DUE TO A MASSIVE SADDLE PULMONARY EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116743 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. Q516498

    Patients

    Seq Age Sex Outcome Treatment
    1 Death