BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER

    MDR report key: 10646057 · Received October 7, 2020

    Report

    Report Number
    1625425-2020-00566
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    May 22, 2014
    Report Date
    October 7, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INDICATED AS UNAVAILABLE FOR EVALUATION. WITHOUT THE DEVICE OR ANY IMAGES IN-VIVO TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION VENA CAVA FILTER ON OR ABOUT (B)(6) 2014 BY DR. BILLY KIM AT SUMMIT MEDICAL CENTER IN HERMITAGE, TENNESSEE. THE COMPLAINT ALLEGES THERE WAS TILT AND PERFORATION POST-IMPLANT. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104623 OPTION RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER DTK ARGON MEDICAL DEVICES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other