BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 15621353 · Received October 18, 2022

    Report

    Report Number
    3004450998-2022-00015
    Event Type
    Death
    Date Received
    October 18, 2022
    Date of Event
    November 4, 2021
    Report Date
    October 17, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    OAZ
    UDI-DI
    00896506002200
    PMA / PMN Number
    HDE H060002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SPIRATION VALVES WERE USED TO TREAT BRONCHOPLEURAL FISTULA. THIS IS AN OFF-LABEL USE. ADVERSE EVENT OF BRADYCARDIA AND HYPOXIA RESOLVED ONCE VALVES WERE REMOVED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED A REPORT FROM USER FACILITY STATING A PATIENT ADMITTED WITH COVID WAS EXPERIENCING AIR LEAKS FROM BOTH OF HIS CHEST TUBES SUGGESTING BRONCHOPLEURAL FISTULA. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN ENDOBRONCHIAL VALVE PLACEMENT. ON (B)(6) 2021 THREE SPIRATION VALVES WERE PLACED FOR THE TREATMENT OF THE BRONCHOPLEURAL FISTULA. TREATMENT WAS UNSUCCESSFUL AS PATIENT BECAME BRADYCARDIC AND HYPOXIC. VALVES WERE REMOVED AND THE BRADYCARDIA AND HYPOXIA RESOLVED. ON (B)(6) 2021 THE PATIENT DEVELOPED HYPOTENSION AND BRADYCARDIA AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS STARTED AND PATIENT ACHIEVED RETURN OF SPONTANEOUS CIRCULATION, THOUGH CONTINUED TO ARREST SEVERAL MORE TIMES DESPITE FULL MEDICAL RESUSCITATION. THE PATIENT PASSED AWAY SEVERAL MINUTES LATER AFTER EXPERIENCING ANOTHER CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360549 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE OAZ GYRUS ACMI, INC. HUS-V9 UNKNOWN 00896506002200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death