MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number	ZEPHYR 4.0 EBV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Pneumothorax (2012)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The patient underwent blvr on (b)(6) 2024 with implantation of 5 valves in the right upper and right middle lobes.On (b)(6) 2024, the patient experienced a pneumothorax, and a chest tube was placed.On (b)(6) 2024, the chest tube was placed on a water seal.On (b)(6) 2024, the patient underwent a thoracoscopy and pleurodesis was performed in addition to a right middle lobe blebectomy to address the alveolar pleural fistula.The patient was transferred to the icu.On (b)(6) 2024, the patient tested positive for mrsa pneumonia and put on iv antibiotics.On (b)(6)2024, one valve was explanted.On (b)(6)2024, a second chest tube was inserted.On (b)(6)2024, the remaining valves were explanted.On (b)(6)2024, a single valve was implanted to address the ongoing air leak.The patient was discharged to long-term care on (b)(6)2024, with the pneumothorax ongoing.Further information will be reported once available.
Event or Problem Description
The patient underwent blvr on (b)(6) 2024 with implantation of 5 valves in the right upper and right middle lobes.On (b)(6) 2024, the patient experienced a pneumothorax, and a chest tube was placed.On (b)(6) 2024, the chest tube was placed on a water seal.On (b)(6) 2024, the patient underwent a thoracoscopy and pleurodesis was performed in addition to a right middle lobeblebectomy to address the alveolar pleural fistula.The patient was transferred to the icu.On (b)(6) 2024, the patient tested positive for mrsa pneumonia and put on iv antibiotics.On (b)(6) 2024, one valve was explanted.On (b)(6) 2024, a second chest tube was inserted.On (b)(6) 2024, the remaining valves were explanted.On (b)(6) 2024, a single valve was implanted to address the ongoing air leak.The patient was discharged to long-term care on (b)(6) 2024, with the pneumothorax ongoing.The patient had chest tubes removed and was discharged (b)(6) 2025.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Common Device Name: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: terry solomon ; 700 chesapeake drive; redwood city, CA 94063
• MDR Report Key: 20883240
• Report Number: 3007797756-2024-00106
• Device Sequence Number: 7902336
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)506981V70(17)261027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 506981-V7.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White