BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 10546132 · Received September 17, 2020

    Report

    Report Number
    1625425-2020-00524
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    April 14, 2017
    Report Date
    September 16, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DTK
    UDI-DI
    00886333217151
    PMA / PMN Number
    K133243
    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 ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2017 BY DR. CHARLES KIM AT DUKE RALEIGH HOSPITAL IN RALEIGH, NORTH CAROLINA. THE COMPLAINT ALLEGES THERE WAS PERFORATION POST-IMPLANT. THE FILTER REMAINS IMPLANTED TODAY. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011562 OPTION ELITE RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER DTK ARGON MEDICAL DEVICES 352506070E UNKNOWN 00886333217151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other