BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 10252778 · Received July 9, 2020

    Report

    Report Number
    3007797756-2020-00150
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    January 30, 2020
    Report Date
    June 9, 2020
    Product Code
    NJK
    UDI-DI
    00811907030119
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HYPOXIA IS A 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), 5.5% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED HYPOXIA IN THE TREATMENT PERIOD ([LESS THAN OR EQUAL TO 45 DAYS). THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE HYPOXIA 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 TO THE ZEPHYR VALVE TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT HAD THREE ZEPHYR VALVES IMPLANTED IN THE LEFT UPPER LOBE. THE PATIENT SUFFERED HYPOXEMIA AFTER ATELECTASIS. THE PATIENT WAS PUT ON OXYGEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716926 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 4.0-LP EBV 504527-V7.0 00811907030119

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| O