BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 11631703 · Received April 7, 2021

    Report

    Report Number
    3007797756-2021-00054
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 7, 2021
    Product Code
    NJK
    UDI-DI
    00811907030423
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PLEURAL EFFUSION IS A KNOWN, ANTICIPATED SIDE EFFECT ASSOCIATED WITH THE ZEPHYR VALVE TREATMENT (CRINER ET AL. A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF ZEPHYR ENDOBRONCHIAL VALVE TREATMENT IN HETEROGENEOUS EMPHYSEMA (LIBERATE). AM J RESPIR CRIT CARE MED. 2018; 198 (9): 1151-1164). IN THE LIBERATE STUDY (IDE CLINICAL STUDY USED TO SUPPORT PMA P180002'S APPROVAL), 7.0% OF THE ZEPHYR VALVE SUBJECTS AND 0% OF THE CONTROL SUBJECTS EXPERIENCED PLEURAL EFFUSION DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). THE ZEPHYR EBV SYSTEM IFU SPECIFICALLY REFERENCES PLEURAL EFFUSION AS A KNOWN SIDE EFFECT OF THIS PROCEDURE. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN EXPECTED SIDE EFFECT OF THE ZEPHYR VALVE TREATMENT. THE REPORTED EVENT WAS FORESEEABLE AND CLINICALLY ACCEPTABLE IN VIEW OF THE EXPECTED PATIENT BENEFIT FROM THE TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH THREE ZEPHYR VALVES IMPLANTED IN THE RIGHT UPPER LOBE. THE POST-PROCEDURE X-RAY SHOWED A LOCULATED EFFUSION. THE PATIENT HAD ANOTHER BRONCHOSCOPY PROCEDURE TO CLEAR SECRETIONS ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT HAD A CT SCAN TO ADDRESS THE EFFUSION AND 2 CHEST DRAINS WERE PLACED. AFTER RESOLUTION, BOTH CHEST DRAINS WERE REMOVED ON (B)(6) 2021 AND PATIENT WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524825 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 5.5-LP EBV 504831-V7.0 00811907030423

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R