BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 9880173 · Received March 25, 2020

    Report

    Report Number
    3007797756-2020-00074
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 25, 2020
    Product Code
    NJK
    UDI-DI
    00811907030423
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DECREASED OXYGEN SATURATION 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), 0.8% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED DECREASED OXYGEN SATURATION DURING THE TREATMENT PERIOD ([LESS THAN OR EQUAL TO 45 DAYS). 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 · 1

    ON (B)(6) 2020 THE PATIENT HAD ZEPHYR VALVES IMPLANTED. THE PATIENT REQUIRED MAXIMUM OXYGEN IN RECOVERY AND O2 SATURATION WAS 86. AFTER A FEW HOURS OF OBSERVATION, THE O2 SATURATION REMAINED LOW. THE DECISION WAS MADE TO EXPLANT ALL ZEPHYR VALVES. ONCE THE VALVES WERE REMOVED, THE O2 SATURATION WAS 97 ON MAXIMUM OXYGEN. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343077 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 5.5-LP EBV 504636-V7.0 00811907030423

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R