BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 17934837 · Received October 13, 2023

    Report

    Report Number
    3007797756-2023-00183
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 12, 2023
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    UDI-DI
    00811907030126
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PULMONARY EDEMA IS A RELATED COMPLICATION TO THE ZEPHYR VALVE TREATMENT AND BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH A VERY LOW INCIDENCE. IN THE LIBERATE STUDY (IDE CLINICAL STUDY USED TO SUPPORT PMA P180002'S APPROVAL), THERE WAS ONE REPORTED EVENT OF PULMONARY EDEMA OUT OF 128 TREATED PATIENTS. THERE HAS BEEN A PRIOR REPORT OF PULMONARY EDEMA IN COMPLAINT HISTORY. THE EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS A RELATED, POTENTIAL COMPLICATION TO THE ZEPHYR VALVE TREATMENT WITH A LOW PROBABILITY OF OCCURRENCE.

    Description of Event or Problem · 0

    THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH FIVE ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE ON (B)(6) 2023. THE PATIENT HAS A HISTORY OF CONGESTIVE HEART FAILURE. THE DAY AFTER THE BLVR PROCEDURE, THE PATIENT HAD ASYMMETRIC PULMONARY EDEMA WITH INCREASED OXYGEN REQUIREMENTS. THE PATIENT'S BASELINE OXYGEN REQUIREMENT WAS 4 - 8 L, AND IT WAS INCREASED TO 10 L. THE PHYSICIAN REMOVED ALL VALVES ON (B)(6) 2023. AFTER RESOLUTION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023 ON 7 L OF OXYGEN WITH INSTRUCTIONS TO WEAN AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704797 ZEPHYR ENDOBRONCHIAL VALVE ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0 EBV 506089-V7.0 00811907030126

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization