BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 14466262 · Received May 21, 2022

    Report

    Report Number
    3004450998-2022-00008
    Event Type
    Injury
    Date Received
    May 21, 2022
    Date of Event
    April 23, 2022
    Report Date
    May 20, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    NJK
    UDI-DI
    00896506002309
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF FIVE VALVES WERE PLACED IN THE PATIENT (THREE SVS-V9-00 AND TWO SVS-V7-00) FOR A TOTAL OF FIVE RELATED EVENT REPORTS FILED SEPARATELY ASSOCIATED WITH THE SAME PATIENT PROCEDURE. 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. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    FIVE SPIRATION VALVES (THREE 9MM VALVES, TWO 7MM VALVES) WERE PLACED IN PATIENT¿S LUL DURING BLVR PROCEDURE. THERE WERE NO PRE-PROCEDURAL COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DISCHARGED FROM HOSPITAL. FOUR DAYS AFTER THE PROCEDURE, PATIENT DEVELOPED PNEUMOTHORAX WHICH REQUIRED CHEST TUBE. PNEUMOTHORAX RESOLVED TWO DAYS AFTER TREATMENT. THERE WAS SIGNIFICANT ATELECTASIS NOTED IN THE TREATED LOBE THAT RESOLVED OVER 2-3 DAYS OF GRADUAL REDUCTION. ALL VALVES WERE REMOVED AFTER RESOLUTION OF PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200685 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK GYRUS ACMI, INC SVS-V9-00 WS180754-01 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R