BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 10946260 · Received December 4, 2020

    Report

    Report Number
    3007797756-2020-00269
    Event Type
    Death
    Date Received
    December 4, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 24, 2020
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    UDI-DI
    00811907030324
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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

    ON (B)(6) 2020, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH FOUR ZEPHYR VALVES PLACED IN THE RIGHT UPPER LOBE AND RIGHT MIDDLE LOBE. THE PATIENT RESPONDED WELL AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020. THE TREATING PHYSICIAN RECEIVED UPDATES FROM THE PATIENT VIA TEXT MESSAGES. ON (B)(6) 2020, THE PATIENT TEXTED THE PHYSICIAN THAT HE THOUGHT HE COULD HEAR THE VALVES OPENING WITH BREATHING BUT WAS DOING FINE. ON (B)(6) 2020, THE PATIENT TEXTED THE PHYSICIAN THAT HE WONDERED IF HE WAS COUGHING MORE AFTER THE PROCEDURE BUT HAD CLEAR SPUTUM AND WAS BREATHING FINE. ON (B)(6) 2020, THE PATIENT TEXTED THE PHYSICIAN ABOUT DARK GREEN SPUTUM, AND IN RESPONSE THE PHYSICIAN PRESCRIBED AN ANTIBIOTIC. ON (B)(6) 2020, ACCORDING TO A VERBAL REPORT FROM THE PATIENT'S WIFE, THE PATIENT HAD SHORTNESS OF BREATH, COLLAPSED AND SUFFERED A HEAD INJURY, AND WENT INTO CARDIAC ARREST. THE PATIENT WAS TRANSPORTED TO THE ER OF A HOSPITAL THAT WAS NOT THE TREATING HOSPITAL, WAS RESUSCITATED BUT HAD AN ANOXIC BRAIN INJURY REQUIRING LIFE SUPPORT. LIFE SUPPORT WAS DISCONTINUED ON (B)(6) 2020. THE PHYSICIAN INQUIRED FROM THE WIFE WHETHER THE PATIENT HAD EXPERIENCED A PNEUMOTHORAX TO WHICH SHE SAID YES BUT NO ADDITIONAL DETAILS WERE PROVIDED. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412528 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 5.5 EBV 504600-V7.0 00811907030324

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| H| O| R