BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRINAV INFUSION SYSTEM

    MDR report key: 21567018 · Received March 10, 2025

    Report

    Report Number
    3010909876-2025-01379
    Event Type
    Death
    Date Received
    March 10, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 10, 2025
    Manufacturer
    TRISALUS LIFE SCIENCES
    Product Code
    DQO
    PMA / PMN Number
    K180677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION OR PERFORMANCE ISSUE ASSERTED OR SUSPECTED BASED ON USER FACILITY REPORT. SUBJECT DEVICE NOT AVAILABLE FOR INVESTIGATION, SCRAPPED BY USER FACILITY AT TIME OF PROCEDURE. DEVICE VARIANT (MODEL NUMBER) AND/OR LOT NUMBER NOT REPORTED BY USER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRINAV CATHETER WAS USED IN A ROUTINE THYROID GOITER EMBOLIZATION PROCEDURE EMPLOYING RADIAL APPROACH VIA THE PERIPHERAL VASCULATURE/INFERIOR THYROID ARTERY. EMBOLIZATION WAS SUCCESSFUL AND CARRIED TO STASIS. POST-EMBOLIZATION ANGIOGRAPHY WAS PERFORMED VIA THE TRINAV CATHETER INSTEAD OF THE THROUGH THE BASE CATHETER IN THE SUBCLAVIAN ARTERY. POST-EMBOLIZATION CONTRAST INJECTION VOLUMES AND FORCES WERE HIGH AND THERE WAS NO FORWARD FLOW/ROOM, DUE TO PRESENCE OF SPHERES, RESULTING IN REFLUX. ARTERY WAS SUPERIMPOSED OVER RIBS AND SPINE MAKING VISUALIZATION OF REFLUX DIFFICULT. ORIGIN OF THE LEFT VERTEBRAL ARTERY WAS DOMINANT (LARGER THAN THE RIGHT) AND IMMEDIATELY PROXIMAL TO THE INFERIOR THYROID ARTERY, RESULTING IN HIGH FLOW TO THE POSTERIOR PORTION OF THE BRAIN. PATIENT EXPERIENCED MULTIPLE SMALL STROKES IDENTIFIED VIA POST PROCEDURE MRI, STARTED ON DUAL-ANTIPLATELET MEDICATIONS (ASPIRIN AND PLAVIX, LOADING DOSES), AND MONITORED FOR 24 HOURS. CT SCAN SHOWED A LARGE AMOUNT OF HEMORRHAGE INTO THE LEFT LATERAL VENTRICLE THAT SPREAD INTO ADJACENT VENTRICLES AND RESULTED IN LOSS OF DIFFERENTIATION OF GREY AND WHITE MATTER. THE PATIENT WAS TRANSITIONED TO HOSPICE CARE THAT DAY AND DIED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336141 TRINAV INFUSION SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER DQO TRISALUS LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death