BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 8122613 · Received December 1, 2018

    Report

    Report Number
    3007797756-2018-00007
    Event Type
    Injury
    Date Received
    December 1, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 8, 2019
    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 · 0

    THE CORRECTED DATA IS THE PRODUCT CODE LISTED IN SECTION COMMON DEVICE NAME. THE CORRECT PRODUCT CODE IS NJK. NO OTHER CORRECTIONS HAVE BEEN MADE. ON THE DATE OF THE INITIAL MDR SUBMISSION, THE PRODUCT CODE NJK WAS NOT AVAILABLE IN THE ESUBMITTER SYSTEM SINCE NJK WAS A RELATIVELY NEW CODE. IN ORDER TO SUBMIT WITHIN THE 30-DAY TIMELINE, ANOTHER PRODUCT CODE (OAZ) WAS USED SINCE THE SYSTEM DOES NOT ALLOW THE FIELD TO BE LEFT BLANK.

    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. THE CORRECT PRODUCT CODE "NJK" COULD NOT BE ENTERED INTO THE FIELD USING ESUBMITTER AS THE SYSTEM CALLED IT AN "INVALID" CODE SINCE IT IS A RELATIVELY NEW CODE. IN ORDER TO BE ABLE TO SUBMIT THE MDR ON TIME (WITHIN 30 DAYS), THE PRODUCT CODE "OAZ" WAS USED. PULMONX HAS BEEN TOLD BY FDA CONTACT NATHAN IVEY THAT THE NEW PRODUCT CODE NJK WILL BE AVAILABLE STARTING ON DEC. 3, 2018.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH THREE ZEPHYR VALVES PLACED IN THE RIGHT UPPER LOBE (RB1, RB2, AND RB3). PATIENT SUBSEQUENTLY DEVELOPED A RIGHT-SIDED PNEUMOTHORAX A DAY AFTER THE PROCEDURE. THERE WAS A PERSISTENT AIR LEAK AND THE LUNG DID NOT RE-EXPAND AFTER TUBE THORACOSTOMY. ONE OUT OF THE THREE VALVES WAS REMOVED WITH LUNG RE-EXPANSION. THE DATE OF THE VALVE REMOVAL IS UNKNOWN. AFTER IMPROVEMENT, THE CHEST TUBE WAS REMOVED ON (B)(6) 2018, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961491 ZEPHYR ENDOBRONCHIAL VALVE ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 5.5 EBV 503749-V7.0 00811907030324

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R