BEUDAMED
    FDA Adverse Event Death Summary report: N

    INARI MEDICAL FLOWTRIEVER MECHANICAL THROMBECTOMY DEVICE

    MDR report key: 19069926 · Received April 8, 2024

    Report

    Report Number
    MW5153639
    Event Type
    Death
    Date Received
    April 8, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 4, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DECEDENT EXPERIENCED A CARDIAC TAMPONADE MID-EMBOLECTOMY UTILIZING A FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM AND SUBSEQUENTLY DIED ON THE OPERATING TABLE. DURING THE COURSE AN AUTOPSY, IT WAS FOUND THAT THERE HAD BEEN A PERFORATION OF HIS RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499464 INARI MEDICAL FLOWTRIEVER MECHANICAL THROMBECTOMY DEVICE PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death