BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 16206507 · Received January 19, 2023

    Report

    Report Number
    3004450998-2023-00005
    Event Type
    Death
    Date Received
    January 19, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 19, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    OAZ
    UDI-DI
    00896506002200
    PMA / PMN Number
    HDE H060002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR SPIRATION VALVES (3X HUS-V9, 1X HUS-V7) WERE PLACED IN THE PATIENT. A TOTAL OF FOUR EVENT REPORTS WERE FILED SEPARATELY, ONE REPORT FOR EACH DEVICE. THE IMPLANTING PHYSICIAN STATED THE VALVES PERFORMED AS INTENDED AND THE ADVERSE EVENT WAS DIRECTLY RELATED TO THE PROCEDURE AS PNEUMONIA AND ILD FLARE ARE KNOWN COMPLICATIONS OF BRONCHOSCOPY.

    Description of Event or Problem · 0

    FOUR SPIRATION VALVES WERE PLACED IN THE UPPER RIGHT LOBE OF THE LUNG ON (B)(6) 2022. THE PATIENT DEVELOPED PNEUMONIA/ILD FLARE ON POST-OPERATIVE DAY 1. THERE WAS NO PNEUMONIA IN THE SEGMENT TREATED WITH THE VALVES. THE PATIENT WAS TREATED WITH ANTIBIOTICS, STEROIDS, AND O2 SUPPORT. THE PATIENT WAS SUBSEQUENTLY PLACED IN HOSPICE CARE AND DIED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129101 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE OAZ GYRUS ACMI, INC. HUS-V9 UNKNOWN 00896506002200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H