BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 16475412 · Received March 2, 2023

    Report

    Report Number
    3004450998-2023-00019
    Event Type
    Death
    Date Received
    March 2, 2023
    Report Date
    March 2, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002309
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SVS-V9-00 VALVES WERE PLACED IN THE PATIENT. THREE EVENT REPORTS WERE FILED SEPARATELY, ONE FOR EACH DEVICE. THIS IS REPORT THREE OF THREE. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THIS TIME. PNEUMOTHORAX IS THE MOST COMMON DEVICE RELATED SERIOUS ADVERSE EVENT THAT IS ASSOCIATED WITH THE SPIRATION VALVE SYSTEM. IN THE EMPROVE STUDY, THE INCIDENCE OF SERIOUS PNEUMOTHORAX WAS 14.2%, WITH OVER 75% OF THE SERIOUS PNEUMOTHORAX EVENTS OCCURRING WITHIN THE FIRST 3 DAYS POST-PROCEDURE. EARLY-ONSET PNEUMOTHORAX IN THE TREATMENT GROUP LIKELY RESULTED FROM LUNG CONFORMATION CHANGES DUE TO ACUTE REDUCTION IN LUNG VOLUME BY VALVE THERAPY, TRIGGERING RAPID EXPANSION OF THE IPSILATERAL NON-TARGETED LOBE LEADING TO PNEUMOTHORAX. (CRINER GJ, DELAGE A, VOELKER K, ET AL. IMPROVING LUNG FUNCTION IN SEVERE HETEROGENOUS EMPHYSEMA WITH THE SPIRATION® VALVE SYSTEM (EMPROVE): A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROL TRIAL. AM J RESPIR CRIT CARE MED. 2019;200(11):1354-1362. DOI:10.1164/RCCM.201902-0383OC). HOWEVER, IT SHOULD BE NOTED THAT PNEUMOTHORAX EVENTS ARE ALSO RECOGNIZED AS AN INDICATOR OF SUCCESSFUL TARGET LOBE OCCLUSION AND WHEN MANAGED ACCORDING TO PUBLISHED EXPERT GUIDELINES (VALIPOUR A, SLEBOS DJ, DE OLIVEIRA HG, ET AL. EXPERT STATEMENT: PNEUMOTHORAX ASSOCIATED WITH ENDOSCOPIC VALVE THERAPY FOR EMPHYSEMA -- POTENTIAL MECHANISMS, TREATMENT ALGORITHM AND CASE EXAMPLES. RESPIRATION 2004 2014;87(6): 513-521. DOI:10.1159/000360642), SUBJECTS WITH PNEUMOTHORAX EVENTS EXPERIENCED CLINICAL BENEFITS SIMILAR TO THAT IN SUBJECTS WITHOUT PNEUMOTHORAX EVENTS (CRINER GJ, DELAGE A, VOELKER K, ET AL. IMPROVING LUNG FUNCTION IN SEVERE HETEROGENOUS EMPHYSEMA WITH THE SPIRATION VALVE SYSTEM (EMPROVE). A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROL TRIAL. AM J RESPIR CRIT CARE MED. 2019;200(11):1354-1362. DOI:10.1164/RCCM.201902-0383OC). THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE IN THE EMPROVE CLINICAL TRIAL AND IS AN EXPECTED ADVERSE EVENT ASSOCIATED WITH THE SPIRATION VALVE SYSTEM.

    Description of Event or Problem · 0

    THE PATIENT HAD THREE (3) VALVES PLACED IN AN UNSPECIFIED SURGICAL PROCEDURE AND WAS DISCHARGED HOME AFTER ONE WEEK. ABOUT FOUR WEEKS AFTER VALVE PLACEMENT, THE PATIENT DEVELOPED A PNEUMOTHORAX AND WAS HOSPITALIZED (AT DIFFERENT HOSPITAL FROM WHERE VALVES WERE PLACED). PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A THIRD HOSPITAL WHERE ALL VALVES WERE REMOVED. PATIENT DEVELOPED PNEUMONIA. PATIENT WAS INTUBATED AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023247 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V9-00 WS236406 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death| H