BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 6MM

    MDR report key: 16535021 · Received March 13, 2023

    Report

    Report Number
    3004450998-2023-00025
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 13, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002293
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SPIRATION VALVES WERE PLACED IN THE PATIENT. THREE EVENT REPORTS WERE FILED SEPARATELY, ONE FOR EACH DEVICE. THIS IS REPORT THREE OF THREE.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. OI: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. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THREE SPIRATION VALVES (1X SVS-V6-00, 2X SVS-V7-00) WERE SUCCESSFULLY PLACED IN PATIENT'S RIGHT UPPER LUNG FOR THE TREATMENT OF EMPHYSEMA (B)(6) 2023. PATIENT EXPERIENCED PNEUMOTHORAX IN THE VALVE TREATED LOBE ON (B)(6) 2023 AND RETURNED TO HOSPITAL. CHEST TUBE WAS PLACED. PATIENT RECOVERED FROM PNEUMOTHORAX. CHEST TUBE WAS REMOVED AND PATIENT WAS DISCHARGED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756888 VALVE IN CARTRIDGE, 6MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V6-00 WS134429-01 00896506002293

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization