BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 10277381 · Received July 15, 2020

    Report

    Report Number
    3004450998-2020-00015
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 15, 2020
    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 · 1

    A TOTAL OF FOUR SVS-V9-00 VALVES WERE PLACED IN THE PATIENT. THIS REPORT ONE OF FOUR REPORTED EVENTS FILED FOR THE SAME PATIENT. 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 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 · 1

    PATIENT WAS ADMITTED TO HOSPITAL ONE WEEK AFTER PLACEMENT OF FOUR (4) SVS-V9-00 VALVES FOR TENSION PNEUMOTHORAX. PATIENT WAS HOSPITALIZED FOR 12 DAYS WHILE THE PNEUMOTHORAX RESOLVED. PATIENT WAS DISCHARGED AND VALVES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742123 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK SVS-V9-00 UNKNOWN 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization