BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINAV INFUSION SYSTEM

    MDR report key: 22301721 · Received June 20, 2025

    Report

    Report Number
    3010909876-2025-01413
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 23, 2025
    Manufacturer
    TRISALUS LIFE SCIENCES, INC.
    Product Code
    DQO
    PMA / PMN Number
    K180677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT DEVICE SCRAPPED BY USER FACILITY AT TIME OF EVENT AND NOT MADE AVAILABLE FOR PHYSICAL EVALUATION. NO DEVICE DEFECT OR FAILURE MODE ASSERTED BY THE USER FACILITY. DEVICE UDI AND LOT NUMBER NOT REPORTED BY USER FACILITY.

    Description of Event or Problem · 0

    A PATIENT WITH GRAVES' DISEASE RESULTING IN SYMPTOMATIC HYPERTHYROIDISM WISHED TO AVOID THYROIDECTOMY AND RADIATION THERAPY FOR TREATMENT. THEREFORE, THYROID ARTERIAL EMBOLIZATION WAS PERFORMED. THE GOAL WAS TO REDUCE THYROID FUNCTION BY EMBOLIZING ONE OF THE TWO THYROID ARTERIES ON EACH SIDE OF THE GLAND (TWO OF THE FOUR IN TOTAL). THE PHYSICIAN SELECTED THE RIGHT SUPERIOR THYROID ARTERY AND TREATED FROM A FEMORAL ARTERY APPROACH AND EMBOLIZATION WAS PERFORMED WITHOUT COMPLICATION. THE PHYSICIAN THEN SELECTED THE LEFT INFERIOR THYROID ARTERY WITH A 5 FRENCH BASE CATHETER AND PERFORMED A PRE-EMBOLIZATION ANGIOGRAM. THE TRINAV DEVICE WAS THEN ADVANCED THROUGH THE BASE CATHETER AND INTO THE PROXIMAL THYROID ARTERY. THE VALVE WAS POSITIONED IN A SHARP TURN, NEAR THE ORIGIN OF THE INFERIOR THYROID ARTERY AFTER STATING THAT HE WOULD TREAT FROM THAT CATHETER POSITION (WITHIN A CURVE IN THE PROXIMAL INFERIOR THYROID). THE PHYSICIAN BEGAN EMBOLIZATION CONTINUING UNTIL HE BELIEVED STASIS HAD BEEN ACHIEVED. THE TRINAV CATHETER WAS REMOVED. SHORTLY THEREAFTER, THE PHYSICIAN PERFORMED A CONE BEAM CT, WHICH DEMONSTRATED NON-TARGET EMBOLIZATION. A POST-PROCEDURE ANGIOGRAM WITH CONTRAST INJECTION WAS THEN PERFORMED VIA THE BASE CATHETER IN THE LEFT SUBCLAVIAN ARTERY, ALTHOUGH THIS WAS NOT ADVISED DUE TO POTENTIAL FOR DISPLACEMENT OF EMBOLIC PARTICLES IN THE INFERIOR THYROID ARTERY. THE ANGIOGRAM SHOWED NO FLOW IN THE INFERIOR THYROID ARTERY DUE TO STASIS. THE PATIENT BEGAN TO EXPERIENCE STROKE SYMPTOMS AFTER ANGIOGRAPHY VIA THE BASE CATHETER, INCLUDING DYSARTHRIA AND INABILITY TO FOLLOW COMMANDS. THE PATIENT BECAME NON-VERBAL, HYPERTENSIVE AND BRADYCARDIC, REQUIRING INTUBATION. MRI SHOWED INFARCTIONS IN THE LEFT POSTERIOR CIRCULATION OF THE BRAIN, INCLUDING CEREBELLUM, OCCIPITAL LOBE AND THALAMUS. TRISALUS' MEDICAL DIRECTOR MADE CONTACT WITH THE TREATING PHYSICIAN AT THE USER FACILITY AFTER SEVERAL ATTEMPTS. THE PHYSICIAN STATED THAT AFTER REFLECTION, LITERATURE REVIEW, AND IMAGING REVIEW, HE BELIEVES HE EMBOLIZED THE INFERIOR THYROID ARTERY BEYOND WHAT WAS APPROPRIATE AND THEREBY CREATED AN INCREASE IN PRESSURE. THIS WAS PARTIALLY DUE TO EMBOLIZATION OF THE OTHER SIDE (THE RIGHT SUPERIOR THYROID ARTERY), WHICH OCCLUDED ANASTOMOSES THAT WOULD HAVE ALLOWED FOR DISSIPATION OF PRESSURE. HE BELIEVES THE VALVE FUNCTIONED WELL AND TRAPPED PRESSURE WITHIN THE EMBOLIZED ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362553 TRINAV INFUSION SYSTEM CONTINUOUS FLUSH CATHETER DQO TRISALUS LIFE SCIENCES, INC. TNV-21150-35 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other