BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 7MM

    MDR report key: 15716240 · Received November 2, 2022

    Report

    Report Number
    3004450998-2022-00016
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 2, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002279
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SPIRATION VALVES (ONE SVS-V9-00 AND ONE SVS-V7-00) WERE PLACED IN THE PATIENT. A TOTAL OF TWO REPORTS ASSOCIATED WITH THE SAME PATIENT WERE FILED SEPARATELY, ONE REPORT FOR EACH DEVICE. 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

    PATIENT WAS TREATED FOR EMPHYSEMA. TWO SPIRATION VALVES (ONE SVS-V9-00 AND ONE SVS-V7-00) WERE PLACED ON (B)(6) 2022. FIVE DAYS POST PROCEDURE (ON (B)(6) 2022), THE PATIENT EXPERIENCED PNEUMOTHORAX AND CODED AT HOME. PATIENT RETURNED TO HOSPITAL AND CODED AGAIN. A CHEST TUBE WAS INSERTED TO RESOLVE THE PNEUMOTHORAX. PATIENT RECOVERED FROM THE PNEUMOTHORAX AND WAS RELEASED FROM HOSPITAL WITH THE VALVES IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275733 VALVE IN CARTRIDGE, 7MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V7-00 235361 -01 00896506002279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| H