BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 9950181 · Received April 10, 2020

    Report

    Report Number
    3007797756-2020-00097
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 12, 2020
    Product Code
    NJK
    UDI-DI
    00811907030126
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    PATIENT UNDERWENT BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE COMPLICATED BY PNEUMOTHORAX AND ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION AND CHEST TUBE PLACEMENT. PATIENT HAD PROLONGED HOSPITALIZATION COMPLICATED BY PNEUMONIA AND ACUTE RENAL FAILURE REQUIRING DIALYSIS. PATIENT SUBSEQUENTLY HAD A TRACHEOSTOMY PLACED AND RECOVERED. PATIENT WAS DISCHARGED TO LONG-TERM ACUTE CARE FOR LOWER LEVEL OF CARE TO CONTINUE VENT WEANING AND OCCUPATIONAL THERAPY OR PHYSICAL THERAPY FOR PROFOUND WEAKNESS.

    Additional Manufacturer Narrative · 1

    PNEUMONIA IS AN ANTICIPATED, POTENTIAL 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), 0.8% OF THE ZEPHYR VALVE SUBJECTS VS. 0% OF THE CONTROL SUBJECTS EXPERIENCED A PNEUMONIA SERIOUS ADVERSE EVENT (SAE) DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). 5.7% OF THE ZEPHYR VALVE SUBJECTS VS. 8.1% OF THE CONTROL SUBJECTS EXPERIENCED A PNEUMONIA SAE DURING THE LONGER-TERM PERIOD FROM 45 DAYS AFTER THE STUDY PROCEDURE THROUGH 12 MONTHS POST-PROCEDURE. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE PNEUMONIA AS A KNOWN, POTENTIAL SIDE EFFECT OF THIS PROCEDURE AND PROVIDE GUIDELINES FOR MONITORING. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN ANTICIPATED, POTENTIAL SIDE EFFECT TO THE ZEPHYR VALVE TREATMENT. THE REPORTED EVENT WAS FORESEEABLE AND CLINICALLY ACCEPTABLE IN VIEW OF THE EXPECTED PATIENT BENEFIT FROM THE TREATMENT. RESPIRATORY FAILURE IS AN ANTICIPATED, POTENTIAL 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), 1.6% OF THE ZEPHYR VALVE SUBJECTS VS. 0% OF THE CONTROL SUBJECTS EXPERIENCED A RESPIRATORY FAILURE SERIOUS ADVERSE EVENT (SAE) DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). 0.8% OF THE ZEPHYR VALVE SUBJECTS VS. 3.2% OF THE CONTROL SUBJECTS EXPERIENCED A RESPIRATORY FAILURE SAE DURING THE LONGER-TERM PERIOD FROM 45 DAYS AFTER THE STUDY PROCEDURE THROUGH 12 MONTHS POST-PROCEDURE. THE ZEPHYR EBV SYSTEM IFU AND PULMONX TRAINING PROGRAM BOTH SPECIFICALLY REFERENCE RESPIRATORY FAILURE AS A KNOWN, POTENTIAL SIDE EFFECT OF THIS PROCEDURE AND PROVIDE GUIDELINES FOR MONITORING. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND IS AN ANTICIPATED, POTENTIAL SIDE EFFECT TO THE ZEPHYR VALVE TREATMENT. THE REPORTED EVENT WAS FORESEEABLE AND CLINICALLY ACCEPTABLE IN VIEW OF THE EXPECTED PATIENT BENEFIT FROM THE TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, PATIENT UNDERWENT BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE AND THREE ZEPHYR 4.0 ENDOBRONCHIAL VALVES WERE PLACED. AFTER THE PROCEDURE, PATIENT DEVELOPED PNEUMONIA AND RESPIRATORY FAILURE AND HAD TO BE RE-INTUBATED. ON (B)(6) 2020, VALVES WERE EXPLANTED. AT THE TIME OF THIS INITIAL REPORT, ONLY VERY LIMITED INFORMATION ABOUT THIS EVENT HAS BEEN OBTAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SITE BUT IS PENDING AND MAY BE DELAYED DUE TO THE PANDEMIC. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THIS INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412181 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 4.0 EBV 504619-V7.0 00811907030126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention