BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION IVC FILTER

    MDR report key: 8514538 · Received April 15, 2019

    Report

    Report Number
    1625425-2019-00072
    Event Type
    Injury
    Date Received
    April 15, 2019
    Report Date
    March 26, 2019
    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
    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 (B)(6) 2019, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE RETRIEVABLE IVC FILTER ON OR ABOUT (B)(6) 2015 BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). THE COMPLAINT SPECIFICALLY ALLEGES ¿RECURRENT/PROGRESSIVE DVT WITH SIGNIFICANT STENOSIS; MURAL THROMBUS OF CFV, SFV, CPV WITH RECANALIZATION; CHRONIC VENOUS INSUFFICIENCY WITH ULCERATION; LOWER EXTREMITY SWELLING/PAIN; ALL 6 PRIMARY STRUTS PERFORATE IVC WALL; DIMINUTIVE IVC DUE TO LONG-STANDING THROMBUS.¿ ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307902 OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. Q748837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other