BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMNO EVOLUTION®

    MDR report key: 19306714 · Received May 13, 2024

    Report

    Report Number
    3011642792-2024-00025
    Event Type
    Death
    Date Received
    May 13, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 3, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS
    Product Code
    FCG
    UDI-DI
    00884450443422
    PMA / PMN Number
    K024120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING A BIOPSY PROCEDURE. POST-BIOPSY PROCEDURE THE PATIENT PRESENTED WITH AIR EMBOLI SYMPTOMS. MEDICAL INTERVENTION WAS NECESSARY TO PREVENT PERMANENT IMPAIRMENT. SUPPORTIVE THERAPY CONSISTING OF SUPPLEMENTAL OXYGEN ADMINISTRATION, INTRAVASCULAR VOLUME EXPANSION, AND BLOOD PRESSURE SUPPORT WAS ATTEMPTED. THE PATIENT WAS TREATED IN A HYPERBARIC CHAMBER IN AN ATTEMPT TO BETTER MANAGE THEIR CONDITION HOWEVER THIS WAS NOT SUCCESSFUL. THE PATIENT HAD EXPERIENCED SUSTAINED SEIZURES AFTER THE INCIDENT AS WELL AND ALL ATTEMPTS TO REDUCE PROCEDURE SEDATION WERE UNSUCCESSFUL. EVENTUALLY, THE PATIENT SUCCUMBED TO THE EFFECTS OF THE INCIDENT AND DIED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755794 TEMNO EVOLUTION® BIOPSY NEEDLE KIT FCG MERIT MEDICAL SYSTEMS I2549253 00884450443422

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| D| L| H