BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 16791814 · Received April 21, 2023

    Report

    Report Number
    3007797756-2023-00069
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    January 4, 2023
    Report Date
    April 20, 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

    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. 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 PATIENT HAD BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURES PERFORMED ON (B)(6) 2022 AND (B)(6) 2022 WITH ZEPHYR VALVES IMPLANTED IN THE LEFT LOWER LOBE. THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO ACUTE HYPERCAPNIC RESPIRATORY FAILURE ON (B)(6) 2023. ADDITIONALLY, THE PATIENT HAD COPD EXACERBATION, RIGHT BASAL LUNG DISEASE AND STREPTOCOCCUS PNEUMONIAE SEPSIS. THE PHYSICIAN DECIDED TO REMOVE ALL VALVES ON (B)(6) 2023 DUE TO REPEATED BRONCHOPULMONARY INFECTIONS AND LACK OF IMPROVEMENT WITH DYSPNEA. THE PATIENT WAS GIVEN CEFOTAXIME ANTIBIOTIC AND NON-INVASIVE VENTILATION. THE ADVERSE EVENTS WERE RESOLVED ON (B)(6) 2023, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807510 ZEPHYR ENDOBRONCHIAL VALVE ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0 EBV 505689- V7.0 00811907030119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R