BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 16660092 · Received March 31, 2023

    Report

    Report Number
    3007797756-2023-00059
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    November 30, 2022
    Report Date
    March 31, 2023
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    UDI-DI
    00811907030317
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESPIRATORY FAILURE IS AN ANTICIPATED, POTENTIAL 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), 1.6% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED RESPIRATORY FAILURE DURING THE TREATMENT PERIOD ([LESS THAN OR EQUAL TO 45 DAYS). 0.8% OF THE ZEPHYR VALVE SUBJECTS AND 3.2% OF THE CONTROL SUBJECTS EXPERIENCED RESPIRATORY FAILURE DURING THE LONGER-TERM PERIOD FROM 45 DAYS AFTER THE STUDY PROCEDURE THROUGH 12 MONTHS POST-PROCEDURE. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE RESPIRATORY FAILURE AS A KNOWN SIDE EFFECT OF THIS PROCEDURE. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN ANTICIPATED, POTENTIAL SIDE EFFECT TO THE ZEPHYR VALVE TREATMENT. THE REPORTED EVENT WAS FORESEEABLE AND CLINICALLY ACCEPTABLE IN VIEW OF THE EXPECTED PATIENT BENEFIT FROM THE TREATMENT. COPD EXACERBATION IS AN ANTICIPATED, POTENTIAL 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), 7.8% OF THE ZEPHYR VALVE SUBJECTS VS. 4.8% OF THE CONTROL SUBJECTS EXPERIENCED A COPD EXACERBATION SERIOUS ADVERSE EVENT (SAE) DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). 23.0% OF THE ZEPHYR VALVE SUBJECTS VS. 30.6% OF THE CONTROL SUBJECTS EXPERIENCED A COPD EXACERBATION SAE DURING THE LONGER-TERM PERIOD FROM 45 DAYS AFTER THE STUDY PROCEDURE THROUGH 12 MONTHS POST-PROCEDURE. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE COPD EXACERBATION AS A KNOWN, POTENTIAL SIDE EFFECT OF THIS PROCEDURE AND PROVIDE GUIDELINES FOR MONITORING. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN ANTICIPATED, POTENTIAL SIDE EFFECT TO 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 UNDERWENT BRONCHOSCOPIC LUNG VOLUME REDUCTION WITH PLACEMENT OF SIX ZEPHYR VALVES IN A TWO-PROCEDURE APPROACH WITH VALVES IMPLANTED ON (B)(6) 2021.ON (B)(6) 2022, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR COPD EXACERBATION. THE SUBJECT EXPERIENCED INFECTIOUS EXACERBATION WITH ACUTE RESPIRATORY FAILURE. THE SUBJECT WAS PLACED ON ANTIBIOTICS. ALL SIX ZEPHYR VALVES WERE REMOVED ON (B)(6) 2022. THE SUBJECT WAS DISCHARGED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397400 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 5.5 EBV 505243-V7.1 00811907030317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R