BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 12078907 · Received June 28, 2021

    Report

    Report Number
    3004450998-2021-00016
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 28, 2021
    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 THREE VALVES WERE PLACED IN THE PATIENT (ONE SVS-V7-00 AND TWO SVS-V9-00) FOR A TOTAL OF THREE RELATED EVENT REPORTS ASSOCIATED WITH 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 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.

    Description of Event or Problem · 1

    THREE VALVES (ONE SVS-V7-00 AND TWO SVS-V9-00) WERE PLACED IN THE PATIENT'S LEFT UPPER LOBE FOR THE TREATMENT OF EMPHYSEMA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND VALVES PERFORMED AS INTENDED. APPROXIMATELY 11 HOURS AFTER THE VALVE PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PNEUMOTHORAX DIRECTLY RELATED TO BOTH THE VALVE AND PROCEDURE REQUIRING CHEST TUBE PLACEMENT. ATELECTASIS WAS ALSO NOTED IN THE TREATED LOBE. THE VALVES WERE SUBSEQUENTLY REMOVED. THE PATIENT RECOVERED. THE PATIENT'S HOSPITAL STAY WAS EXTENDED AS A RESULT OF THE PNEUMOTHORAX. EVENT WAS NOTED TO BE RELATED TO THE LUNG VOLUME REDUCTION WITH SUBSEQUENT PLEURAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977627 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK SVS-V9-00 WS123128-01 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention