BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM

    MDR report key: 12915851 · Received December 2, 2021

    Report

    Report Number
    0001625425-2021-01182
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    September 23, 2010
    Report Date
    December 2, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    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) 2010 BY DR. STEPHANIE LIN AT SAN MATEO MEDICAL CENTER IN SAN MATEO, CALIFORNIA. THE COMPLAINT ALLEGES THERE WAS TILT, FRACTURE, AND PERFORATION. THE FILTER WAS NOT RETRIEVED. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818035 OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM OPTION DTK ARGON MEDICAL DEVICES 352506070 S30594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other