BEUDAMED
    FDA Adverse Event Death Summary report: N

    INARI FLOWTRIEVER

    MDR report key: 20156800 · Received September 5, 2024

    Report

    Report Number
    MW5159225
    Event Type
    Death
    Date Received
    September 5, 2024
    Report Date
    September 2, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INARI THROMBECTOMY DEVICE USE TO REMOVE TUMOR THROMBUS EXTENDING FROM THE RIGHT HEPATIC VEIN INTO THE RIGHT ATRIUM. INTRA-PROCEDURALLY THE PATIENT SHOWERED TUMOR THROMBUS INTO THE ENTIRE PULMONARY CIRCULATION, WITH IMMEDIATE CARDIOVASCULAR COLLAPSE RESULTING IN SUSTAINED HYPOXIA, HYPOTENSION AND MULTI SYSTEM ORGAN FAILURE. THE PATIENT WAS DOING WELL PRIOR TO THE PROCEDURE. THIS IS DIRECTLY A RESULT OF POOR JUDGEMENT IN USE OF THE DEVICE AND THE DEVICE SHOULD NOT BE USED IN THIS SITUATION. DEATH AT (B)(6) FROM INARI THROMBECTOMY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886794 INARI FLOWTRIEVER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death