BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 11988014 · Received June 11, 2021

    Report

    Report Number
    3007797756-2021-00125
    Event Type
    Death
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    UDI-DI
    00811907030126
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE FEMALE PATIENT, AGED (B)(6) YEARS OLD, WITH A DIAGNOSIS OF COPD/EMPHYSEMA AND A BASELINE HISTORY OF HYPERTENSION, ULCERATIVE COLITIS, AND FIBROMYALGIA HAD BEEN PREVIOUSLY TREATED FOR HER EMPHYSEMA WITH PLACEMENT OF SPIRATION VALVES IN THE LEFT UPPER LOBE (LUL). THE PATIENT UNDERWENT A BRONCHOSCOPY PROCEDURE ON (B)(6) 2021 WHERE THE EXISTING SPIRATION VALVES (PLACED 12 MONTHS AGO) WERE REMOVED (FOR LACK OF EFFECT) FROM THE LUL. SINCE THERE WAS ALSO A TARGET ON THE RIGHT SIDE OF THE LUNG (LITTLE TO NO COLLATERAL VENTILATION) 5 ZEPHYR VALVES WERE PLACED IN THE RIGHT UPPER AND RIGHT MIDDLE LOBE. THE PROCEDURE WAS UNEVENTFUL. THREE DAYS POST-PROCEDURE ((B)(6) 2021), THE PATIENT DEVELOPED PNEUMONIA IN THE LEFT LUNG. THE PNEUMONIA WAS TREATED WITH ANTIBIOTICS AND NEBULIZER THERAPY. THE PATIENT HAD INCREASED OXYGEN NEED AND WAS TRANSFERRED TO THE ICU WHERE THE PATIENT DEVELOPED TAKOTSUBO CARDIOMYOPATHY. THE PATIENT DID NOT RECOVER AND DIED ON (B)(6) 2021. NO AUTOPSY WAS PERFORMED. THE TREATING PHYSICIAN STATED THAT THE PNEUMONIA WAS IN THE LEFT LUNG AND LIKELY NOT RELATED TO THE ZEPHYR VALVES THAT WERE PLACED IN THE RIGHT UPPER AND RIGHT MIDDLE LOBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878470 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 4.0 EBV 504809-V7.0 00811907030126

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R