BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 6MM

    MDR report key: 18145703 · Received November 15, 2023

    Report

    Report Number
    3004450998-2023-00048
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 14, 2023
    Report Date
    December 15, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002293
    PMA / PMN Number
    P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE SPIRATION VALVES WERE PLACED IN THE PATIENT. FIVE EVENT REPORTS WERE FILED SEPARATELY, ONE FOR EACH DEVICE. THIS IS REPORT ONE OF FIVE FOR THE REPORTED PNEUMOTHORAX EVENT. 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. H3 OTHER TEXT: DEVICE DISCARDED AFTER REMOVAL. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT'S CULTURE TEST RESULTS CAME BACK NEGATIVE FOR PNEUMONIA. PATIENT WAS SEEN BY PHYSICIAN 28 DAYS POST HOSPITAL DISCHARGE ((B)(6) 2023). THERE WAS NO EVIDENCE OF AN AIR LEAK. COMPUTED TOMOGRAPHY (CT) CONFIRMED PNEUMOTHORAX RESOLUTION. THE HEIMLICH VALVE (NOT A GYRUS PRODUCT) WAS LEFT IN PLACE BUT WAS SUBSEQUENTLY REMOVED 5 DAYS LATER ((B)(6) 2023).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2023. THE PHYSICIAN PLACED 1X 6MM, 1X 7MM VALVE, AND 1X 9MM VALVE. ONE 9MM VALVE WAS REMOVED DUE TO FIT AND REPLACED WITH A 7MM VALVE. SUBSEQUENTLY TWO ADDITIONAL 9MM VALVES WERE PLACED. IN TOTAL FIVE VALVES WERE PLACED IN THE RIGHT UPPER LOBE. AFTER A FOUR DAY STAY, THE PATIENT WAS RELEASED FROM HOSPITAL WITH NO COMPLICATIONS AT THE TIME OF DISCHARGE. TEN DAYS AFTER VALVE PLACEMENT PROCEDURE ON (B)(6) 2023), THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL. CHEST X-RAY WAS TAKEN, CT SCAN WAS PERFORMED, AND PNEUMOTHORAX WAS CONFIRMED A CHEST TUBE WAS INSERTED TO TREAT THE PNEUMOTHORAX WITH SUCTION. TWENTY-FOUR DAYS AFTER INITIAL VALVE PLACEMENT ON (B)(6) 2023), ALL FIVE VALVES WERE REMOVED DUE TO CONTINUING AIR LEAKS. DURING THE REMOVAL PROCEDURE, AN ABUNDANCE OF MUCOUS WAS OBSERVED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR SUSPECTED PNEUMONIA. THE PATIENT WAS DISCHARGED FROM HOSPITAL FOUR DAYS AFTER VALVE REMOVAL ON (B)(6) 2023) WITH HEIMLICH VALVE IN PLACE FOR PNEUMOTHORAX AND ON ANTIBIOTICS TO TREAT SUSPECTED PNEUMONIA. CULTURE RESULTS WERE REQUESTED BUT TO DATE NO PNEUMONIA HAS BEEN CONFIRMED. THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237534 VALVE IN CARTRIDGE, 6MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V6-00 WS261272 00896506002293

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H