BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 19757386 · Received July 16, 2024

    Report

    Report Number
    3004450998-2024-00031
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    May 18, 2024
    Report Date
    July 16, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002309
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF THREE 9MM VALVES (SVS-V9-00) WERE PLACED IN THE PATIENT FOR A TOTAL OF THREE RELATED EVENT REPORTS FILED SEPARATELY FOR THE SAME PATIENT PROCEDURE. THIS IS REPORT TWO OF THREE ASSOCIATED WITH THIS EVENT. 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 A 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 CONTROLLED CLINICAL 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. 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 CONTROLLED CLINICAL 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

    A PATIENT UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2024. THE PHYSICIAN INITIALLY PLACED THREE SVS-V9-00 VALVES ONE AT A TIME IN LB1; HOWEVER, FOLLOWING REVIEW OF POSITIONING IN ACCORDANCE WITH THE LABELING, THE VALVES WERE REMOVED. THE PHYSICIAN THEN PROCEEDED TO PLACE THREE 9MM VALVES (SVS-V9-00) IN THE PATIENT'S LEFT UPPER LOBE, ONE AT LB1+2, ONE AT LB3, AND ONE AT LB4+5. A POST PROCEDURE CHEST X-RAY CONFIRMED COMPLETE OCCLUSION. TWENTY-FIVE DAYS AFTER THE PROCEDURE ON (B)(6) 2024, THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE VALVE TREATED LOBE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. AFTER A SIX DAY HOSPITAL STAY, THE EVENT WAS RESOLVED WITHOUT SEQUELAE AND THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2024. THE VALVES REMAIN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715262 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V9-00 WS388855 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H