BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRINAV LV INFUSION SYSTEM

    MDR report key: 21827534 · Received April 11, 2025

    Report

    Report Number
    3010909876-2025-01386
    Event Type
    Death
    Date Received
    April 11, 2025
    Date of Event
    March 4, 2025
    Manufacturer
    TRISALUS LIFE SCIENCES
    Product Code
    KRA
    PMA / PMN Number
    K230957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY REPORTED THERE WAS NO EVIDENCE OR SUSPICION OF DEVICE MALFUNCTION. PHYSICIAN COMMENTED THE DEVICE FUNCTIONED WELL AND THERE WAS NO REFLUX OR ANY OTHER ALLEGED PERFORMANCE ISSUE WITH THE CATHETER. DEVICE UDI AND LOT NUMBER NOT REPORTED BY USER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEUROENDOCRINE TUMOR WAS TREATED WITH 3 SYRINGES OF BLAND EMBO BEADS, SIZES 100-500. THE TRINAV LV 120 LENGTH DEVICE WAS USED FOR INFUSION. NO COMPLICATIONS OBSERVED DURING CASE AND PATIENT DISPLAYED NO COMPLICATIONS 2 DAYS POST PROCEDURE. PATIENT DIED 3 DAYS POST PROCEDURE UNEXPECTEDLY AT HOME. CAUSE OF DEATH UNKNOWN. PHYSICIAN UNSURE WHY OR WHAT HAPPENED. THE PHYSICIAN WAS EXPECTING TO TREAT PATIENT MULTIPLE TIMES WITH BLAND EMBO AND WAS NOT EXPECTING SUDDEN DEATH. UPON SUBSEQUENT FOLLOW-UP INVESTIGATION WITH THE USER FACILITY, IT WAS REPORTED THAT ON POST-PROCEDURE DAY NUMBER 3, THE PATIENT BEGAN TO FEEL WEIRD AND SHAKY, SO HE WENT TO THE EMERGENCY DEPARTMENT. HE WAS NOTED TO BE HYPOTENSIVE (BP 90/60) AND HAD ELEVATED LIVER FUNCTION TESTS. TROPONIN AND OTHER CARDIAC LABS WERE NOT ORDERED. THE PATIENT WAS DISCHARGED WITH PAIN MEDICATION. PATIENT HAD A VERY HIGH DISEASE BURDEN AND CARCINOID SYNDROME PRIOR TO TREATMENT. ALTHOUGH HE HAD TAKEN A LONG-ACTING SOMATOSTATIN ANALOGUE (LANREOTIDE), HE WAS AT HIGH RISK FOR CARCINOID CRISIS DUE TO HIS HIGH TUMOR BURDEN. OCTREOTIDE WAS NOT USED FOR PROPHYLAXIS. HIS PRESENTATION TO THE EMERGENCY DEPARTMENT IS VERY CONCERNING FOR CARCINOID CRISIS AND THIS WAS NOT TREATED. IT IS THEREFORE SUSPECT THE PATIENT DIED OF CARCINOID CRISIS AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006667 TRINAV LV INFUSION SYSTEM CONTINUOUS FLUSH CATHETER KRA TRISALUS LIFE SCIENCES TVM-25120-50 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death