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	Pneumonia (2011); Pneumothorax (2012); Respiratory Failure (2484)
Date of Event	05/20/2025
Type of Reportable Event	Death
Event or Problem Description
The patient received 4 valves on (b)(6) 2025.On (b)(6) 2025, the patient was admitted to the hospital with copd exacerbations, pneumonia and rapid decline.The patient was released from the hospital on (b)(6) 2025.Patient expired (b)(6) 2025.
Additional Manufacturer Narrative
Correction of report as this initially submitted report was incorrect.
Event or Problem Description
Three valves were implanted in the right upper lobe.Patient did get a pneumothorax after the procedure.The valves were all eventually removed and the patient refused intubation.Md clarified the valves themselves did not cause the patient death.A narrative has been requested from the md for additional information.

• 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: leah andre ; 700 chesapeake drive; redwood city, CA 94063
• MDR Report Key: 22341987
• Report Number: 3007797756-2025-00026
• Device Sequence Number: 8994127
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)507140V70(17)270307
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 507140-V7.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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: Death
• Patient Sex: Unknown