BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 12029338 · Received June 18, 2021

    Report

    Report Number
    3007797756-2021-00134
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 18, 2021
    Product Code
    NJK
    UDI-DI
    00811907030423
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD ZEPHYR VALVES IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT DEVELOPED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. A SECOND CHEST TUBE WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE CHEST TUBES WERE REMOVED AND THE PATIENT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    PNEUMOTHORAX IS THE MOST COMMON 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). TARGETED LOBAR DEFLATION LIKELY CAUSES INFLATION OF THE IPSILATERAL LOBE, WHICH CAN RESULT IN A TEAR OF THE ALREADY COMPROMISED PARENCHYMAL TISSUE OF THE EMPHYSEMATOUS IPSILATERAL LOBE, RESULTING IN A PNEUMOTHORAX (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), 26.6% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED A PNEUMOTHORAX IN THE TREATMENT PERIOD ([LESS THAN OR EQUAL TO 45 DAYS). THESE WERE MANAGED USING STANDARD OF CARE PROCEDURES AS PER PREVIOUSLY PUBLISHED GUIDELINES (VALIPOUR, ARSCHANG, ET AL. RESPIRATION 87.6 (2014): 513-521). IN 17.4% OF THE EVENTS, THE PNEUMOTHORAX RESOLVED WITHOUT ANY ADDITIONAL INTERVENTION WITH SUBJECTS UNDER CAREFUL OBSERVATION. IN OVER HALF THE EVENTS (56.5%), THE PNEUMOTHORAX WAS MANAGED WITH A CHEST-TUBE ONLY. AN ADDITIONAL 13% OF THE EVENTS WERE MANAGED WITH A CHEST-TUBE AND THE TEMPORARY REMOVAL OF ONE OR MORE VALVES, WHILE ANOTHER 13% OF THE EVENTS WERE MANAGED WITH A CHEST-TUBE AND REMOVAL OF ALL THE IMPLANTED VALVES. UPON SUCCESSFUL RESOLUTION OF THE PNEUMOTHORAX, REMOVED VALVES CAN BE REPLACED. PATIENTS THAT EXPERIENCED A PNEUMOTHORAX EXPERIENCED CLINICAL BENEFITS OF THE ZEPHYR VALVE TREATMENT THAT WERE SIMILAR TO THE BENEFITS EXPERIENCED BY PATIENTS WHO DID NOT HAVE A PNEUMOTHORAX. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE PNEUMOTHORAX AS A KNOWN SIDE EFFECT OF THIS PROCEDURE AND THE PUBLISHED GUIDELINES (VALIPOUR, ARSCHANG, ET AL. "EXPERT STATEMENT: PNEUMOTHORAX ASSOCIATED WITH ENDOSCOPIC VALVE THERAPY FOR EMPHYSEMA-POTENTIAL MECHANISMS, TREATMENT ALGORITHM, AND CASE EXAMPLES." RESPIRATION 87.6 (2014): 513-521). 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

    THE PATIENT HAD ZEPHYR VALVES IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT DEVELOPED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. AN UPDATE WILL BE PROVIDED WHEN MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922922 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 5.5-LP EBV 00811907030423

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R