BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 11807961 · Received May 11, 2021

    Report

    Report Number
    3007797756-2021-00092
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    March 29, 2019
    Report Date
    May 11, 2021
    Product Code
    NJK
    PMA / PMN Number
    P180002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SUBJECT HAD FOUR ZEPHYR VALVES IMPLANTED IN THE LEFT UPPER LOBE ON (B)(6) 2015. THE SUBJECT EXPERIENCED PERSISTENT RESPIRATORY FAILURE AND WAS TREATED WITH A SECONDARY BRONCHOSCOPY FOR BRONCHIAL LAVAGE FOR A MUCAL PLUG ON (B)(6) 2019. THE 5.5 EBV IN THE LINGUAL DIVISION APPEARED TO BE DEFORMED AND WAS NOT OCCLUDING PROPERLY. THE VALVE WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702378 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 5.5 EBV 502645-V7.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention