BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 5MM

    MDR report key: 10260383 · Received July 10, 2020

    Report

    Report Number
    3004450998-2020-00009
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 10, 2020
    Product Code
    NJK
    UDI-DI
    00896506002286
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF SIX VALVES WERE PLACED IN THE PATIENT (2 X SVS-V5-00, 2 X SVS V6-00, AND 2 X SVS-V7-00) FOR A TOTAL OF SIX 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 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT WITH SEVERE EMPHYSEMA HAD SPIRATION VALVES PLACED IN THEIR LUNG. NO PRIOR EVIDENCE OF ATELECTASIS WAS DOCUMENTED. VALVES WERE PLACED INTO RIGHT UPPER LOBE ANTERIOR, APICAL, AND POSTERIOR SUB-SEGMENTS. PATIENT DEVELOPED A PNEUMOTHORAX AN HOUR TO HOUR AND A HALF AFTER PROCEDURE WAS PERFORMED. POST-PROCEDURE CHEST X-RAY AFTER TREATMENT OF PNEUMOTHORAX SHOWED ATELECTASIS AND VOLUME LOSS. INTERVENTIONS TO TREAT PNEUMOTHORAX INCLUDED CONSCIOUS SEDATION AND INSERTED CHEST TUBE WITH IMMEDIATE RESOLUTION. PATIENT EXHIBITED NO DISTRESS. VALVES REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720674 VALVE IN CARTRIDGE, 5MM SPIRATION VALVE 5MM NJK SVS-V5-00 W03428-01 00896506002286

    Patients

    Seq Age Sex Outcome Treatment
    1