BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 18735762 · Received February 19, 2024

    Report

    Report Number
    3007797756-2024-00013
    Event Type
    Death
    Date Received
    February 19, 2024
    Report Date
    February 19, 2024
    Manufacturer
    PULMONX CORPORATION
    Product Code
    NJK
    PMA / PMN Number
    P180002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR FOR THIS EVENT WAS SUBMITTED IN REPORT NUMBER 3007797756-2023-00196. SINCE THAT TIME, ONLY LIMITED INFORMATION WAS MADE AVAILABLE. ADDITIONAL PRODUCT MODELS WERE IDENTIFIED AFTER THE INITIAL MDR WAS SUBMITTED AS IT IS NORMAL TO USE MULTIPLE VALVES IN A SINGLE PROCEDURE, BUT PRODUCT LOT NUMBERS/UDI WERE NOT PROVIDED. 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 HAD A HISTORY OF AORTIC TAVI AND STABLE, HOMOGENOUS EMPHYSEMA. PATIENT WAS A CANDIDATE FOR BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE AND WAS TREATED WITH VALVES PLACED IN THE RIGHT UPPER LOBE (RUL) ON (B)(6) 2023. THE PATIENT EXPERIENCED A PNEUMOTHORAX POST-PROCEDURE, ACROSS FISSURE FROM THE RIGHT LOWER LOBE (RLL). PATIENT HAD DIFFICULTY WAKING UP POST-PROCEDURE AND DESATURATED. A SMALL AMOUNT OF BLOOD WAS OBSERVED IN CHEST DRAIN. THAT SAME EVENING, PATIENT HAD A SECOND BRONCHOSCOPY PROCEDURE AND ONE VALVE WAS REMOVED. THE PNEUMOTHORAX DID NOT APPEAR LARGE, BUT "FROTHY" BLOOD WAS PRESENT. PATIENT WAS SENT TO THE ICU. THE FOLLOWING DAY PATIENT WAS TAKEN TO THE OPERATING ROOM AND A THORACOTOMY PERFORMED AND THE RLL WAS REMOVED SURGICALLY. PATIENT WAS KEPT UNCONSCIOUS AS VERY ANXIOUS WHEN AWAKE. THE FAMILY WITHDREW RESUSCITATION PERMISSION. THE PATIENT DIED ON (B)(6) 2023, 10 DAYS AFTER PROCEDURE. NO OTHER DETAILS WERE MADE AVAILABLE DESPITE MULTIPLE REQUESTS FOR A FULL NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528631 ZEPHYR ENDOBRONCHIAL VALVE ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 5.5 EBV

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Hospitalization| D| R