BEUDAMED
    FDA Adverse Event Death Summary report: Y

    SPIRATION VALVE

    MDR report key: 11572731 · Received March 25, 2021

    Report

    Report Number
    3004450998-2021-00013
    Event Type
    Death
    Date Received
    March 25, 2021
    Date of Event
    August 30, 2020
    Report Date
    March 25, 2021
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED THREE DAYS AFTER PLACEMENT OF THE COMMERCIAL VALVES. NO VALVE INFORMATION (NAME, MODEL, LOT NUMBER, OR NUMBER OF VALVES PLACED), INCLUDING VALVE STATUS (I.E. WHETHER VALVES WERE REMOVED) WAS AVAILABLE AT THE TIME OF THIS REPORT. INVESTIGATOR ASSESSMENT PER STUDY PROTOCOL INDICATED DEVICE RELATIONSHIP WAS ¿PROBABLY NOT RELATED¿ AND PROCEDURE RELATIONSHIP AS ¿DEFINITELY NOT RELATED¿. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    AN (B)(6) STUDY PATIENT, WITH SPIRATION VALVES PLACED APPROXIMATELY 6 YEARS PRIOR TO THE REPORTED EVENT, HAD ELECTIVE BRONCHIAL VALVE PLACEMENT SURGERY WHILE STILL ENROLLED IN THE EMPROVE STUDY. SUBJECT WAS SCHEDULED FOR RELEASE THREE DAYS POST ELECTIVE VALVE PLACEMENT PROCEDURE, HOWEVER PATIENT EXPERIENCED CARDIAC ARREST AND WAS RE-ADMITTED. PATIENT EXPERIENCED A SECOND CARDIAC ARREST THREE DAYS LATER AND PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469672 SPIRATION VALVE SPIRATION VALVE SYSTEM NJK GYRUS ACMI, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death