BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 17007341 · Received May 25, 2023

    Report

    Report Number
    3007797756-2023-00103
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 25, 2023
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    UDI-DI
    00811907030119
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE SUBJECT HAD A ZEPHYR VALVE IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT EXPERIENCED A PLEURAL EFFUSION. THE SUBJECT WAS HOSPITALIZED AND TREATED WITH PLEURAL PUNCTURES, AND WAS DISCHARGED ON (B(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448024 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0 EBV 506023-V7.0 00811907030119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R