BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIRATION VALVE SYSTEM

    MDR report key: 16418842 · Received February 22, 2023

    Report

    Report Number
    3004450998-2023-00014
    Event Type
    Death
    Date Received
    February 22, 2023
    Date of Event
    February 4, 2020
    Report Date
    February 22, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SPIRATION VALVES (MODEL INFORMATION UNKNOWN AT TIME OF REPORT) WERE PLACED IN THE PATIENT. A TOTAL OF THREE EVENT REPORTS WERE FILED SEPARATELY, ONE REPORT FOR EACH DEVICE. THIS IS THE FIRST OF THREE REPORTS. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    ON (B)(6) 2020, PATIENT UNDERWENT BLVR PROCEDURE. THREE (3) SPIRATION ENDOBRONCHIAL VALVES WERE PLACED IN PATIENT¿S LUNGS. IMMEDIATELY UPON INTUBATION, PATIENT EXPERIENCED EXCESS DYNAMIC AIRWAY COLLAPSE SUGGESTIVE OF POTENTIAL RESPIRATORY FAILURE. UPON EXTUBATION, PATIENT¿S ARTERIAL BLOOD GASES SHOWED HYPERCAPNIC RESPIRATORY FAILURE. PATIENT HOSPITAL STAY WAS EXTENDED (22 DAYS) IN WHICH HIS CONDITION PROGRESSIVELY DETERIORATED, ULTIMATELY RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227615 SPIRATION VALVE SYSTEM SPIRATION VALVE NJK GYRUS ACMI, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death