BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE

    MDR report key: 13660294 · Received March 3, 2022

    Report

    Report Number
    3007797756-2022-00048
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 3, 2022
    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

    HEMOPTYSIS 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), 8.6% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED A HEMOPTYSIS EVENT DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). 9.8% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED A HEMOPTYSIS EVENT DURING THE LONGER-TERM PERIOD FROM 45 DAYS AFTER THE STUDY PROCEDURE THROUGH 12 MONTHS POST-PROCEDURE. NONE OF THE HEMOPTYSIS EVENTS REACHED THE THRESHOLD OF "MASSIVE HEMOPTYSIS" PER THE DEFINITION OF GREATER THAN 200 ML BLOOD LOSS IN LESS THAN 24 HOURS. RESPIRATORY TRACT INFECTION 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 EXPERIENCED AN UPPER RESPIRATORY TRACT INFECTION EVENT DURING THE TREATMENT PERIOD (LESS THAN OR EQUAL TO 45 DAYS). 5.7% OF THE ZEPHYR VALVE SUBJECTS EXPERIENCED A UPPER RESPIRATORY TRACT INFECTION EVENT 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 HEMOPTYSIS AND RESPIRATORY TRACT INFECTION AS KNOWN, POTENTIAL SIDE EFFECTS OF THIS PROCEDURE AND PROVIDE GUIDELINES FOR MONITORING. THE REPORTED EVENT ALIGNS WITH THE EXPERIENCE OBSERVED IN THE LIBERATE CLINICAL STUDY AND ARE ANTICIPATED, POTENTIAL SIDE EFFECTS 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 · 0

    THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH FIVE ZEPHYR VALVES PLACED IN THE RIGHT LOWER LOBE ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT HAD A POST-OP CLINIC VISIT AND REPORTED MODERATE IMPROVEMENT IN HIS BREATHING WITH INCREASED ACTIVITY TOLERANCE, BUT ALSO COUGHING FITS SEVERAL TIMES PER DAY WITH SMALL AMOUNTS OF DARK RED HEMOPTYSIS. CHEST X-RAYS SHOWED THERE WAS MILD RIGHT BASAL ATELECTASIS, DECREASED SOMEWHAT FROM THE INITIAL POST-PROCEDURE CHEST X-RAYS, AND A SMALL RIGHT PLEURAL EFFUSION. ON (B)(6) 2022, THE PATIENT WAS SEEN IN HIS LOCAL EMERGENCY DEPARTMENT AFTER ONSET OF INCREASING SHORTNESS OF BREATH AND UPPER RESPIRATORY INFECTION SYMPTOMS SEVERAL DAYS PRIOR. CHEST CT SCAN WAS NEGATIVE FOR PNEUMOTHORAX OR PLEURAL EFFUSION, BUT SHOWED A NEW ROUNDED MASS IN THE RIGHT MIDDLE LOBE (RML). RESPIRATORY VIRAL PANELS WERE NEGATIVE. ON (B)(6) 2022, THE PATIENT SAW HIS LOCAL PULMONOLOGIST AND HAD A SUSPECTED POSSIBLE ASPIRATION EVENT. SPUTUM CULTURE WAS OBTAINED, AND THE PATIENT WAS STARTED ON A 14-DAY COURSE OF CLINDAMYCIN AND A 21-DAY COURSE OF LEVOFLOXACIN. CULTURE CAME BACK POSITIVE FOR (B)(6). ON (B)(6) 2022, THE PATIENT CONTINUED TO HAVE INCREASED SHORTNESS OF BREATH AND CHEST PAIN, NOW REQUIRING SUPPLEMENTAL OXYGEN, AND WAS ADMITTED TO HIS LOCAL HOSPITAL FOR IV ANTIBIOTICS. REPEAT CT SCANS WERE DONE SHOWING SLIGHT DECREASE IN SIZE OF THE RML MASS, BUT WITH EXTENSIVE BRONCHIAL WALL THICKENING AND LIKELY MUCUS PLUGGING. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2022 ON CONTINUED ORAL ANTIBIOTICS. ON (B)(6) 2022, THE PATIENT EXPECTORATED ONE VALVE DURING A COUGHING FIT. ON (B)(6) 2022, THE PATIENT HAD A TELEMEDICINE APPOINTMENT WITH THE TREATING PHYSICIAN. THE PATIENT REPORTED MULTIPLE ED VISITS RELATED TO HIS SHORTNESS OF BREATH. THE TREATING PHYSICIAN REVIEWED ALL OF THE CHEST CTS AND CHEST X-RAYS FROM THE DATE OF THE VALVE PROCEDURE FORWARD AND CONSULTED WITH A RADIOLOGIST. THERE IS EVIDENCE OF THE RIGHT LUNG MASS BEGINNING ON THE CHEST X-RAY ON (B)(6) 2021. THIS APPEARS TO BE A FLUID COLLECTION IN THE JUNCTION OF THE MAJOR AND MINOR FISSURE, RATHER THAN AN INTRAPARENCHYMAL ABSCESS. ON (B)(6) 2022, THE PATIENT ADMITTED TO THE HOSPITAL FOR A PLANNED CT-GUIDED NEEDLE BIOPSY. THEY WERE UNABLE TO DRAIN THE FLUID COLLECTION AS IT WAS TOO THICK, SO MULTIPLE CORE NEEDLED ASPIRATES WERE OBTAINED. THERE WAS A SMALL PNEUMOTHORAX POST-PROCEDURE. THE FINAL PATHOLOGY DIAGNOSIS WAS FIBROSIS WITH MIXED INFLAMMATION, FIBRIN, AND HEMOSIDERIN LADEN MACROPHAGES; ADJACENT LUNG ALVEOLI WITH REACTIVE PNEUMOCYTES AND HEMOSIDERIN LADEN MACROPHAGES; NEGATIVE FOR NEOPLASM. ON (B)(6) 2022, THE PATIENT HAD A SCHEDULED BRONCHOSCOPY FOR VALVE REMOVAL. THE TREATING PHYSICIAN WAS ONLY ABLE TO REMOVE THREE OF THE FOUR REMAINING VALVES. THE MEDIAL BASILAR SEGMENT VALVE COULD BE GRASPED, BUT EFFORTS TO REMOVE IT RESULTED IN SIGNIFICANT AIRWAY BLEEDING REQUIRING PLACEMENT OF A BALLOON CATHETER TO ACHIEVE HEMOSTASIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 IN STABLE CONDITION. ON (B)(6) 2022, THE PATIENT HAD A TELEMEDICINE VISIT WITH THE TREATING PHYSICIAN. THE PATIENT REPORTED HAVING DYSPNEA ON EXERTION REQUIRING SUPPLEMENTAL OXYGEN, COUGH PRODUCTIVE OF OLD BLOOD, PAIN IN THE RIGHT SIDE OF HIS CHEST, AND NOT FEELING WELL. THE PHYSICIAN SUSPECTED THERE IS A SMALL FOCAL AREA OF INFECTION WITH IRRITATION OF THE ADJOINING PLEURA, WHAT HE DESCRIBED AS A MATURE ABSCESS. DUE TO HIS ONGOING SYMPTOMS, THE PATIENT WAS SCHEDULED FOR A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) VERSUS POSSIBLE OPEN DECORTICATION ON (B)(6) 2022. ON (B)(6) 2022, THE PHYSICIAN PERFORMED A VATS PROCEDURE. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2022. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP VISIT ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655884 ZEPHYR ENDOBRONCHIAL VALVE ENDOBRONCHIAL VALVE NJK PULMONX CORPORATION ZEPHYR 5.5 EBV 505437-V7.1 00811907030324

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H