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

Model Number	ZEPHYR VALVE 4.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient received valve placement and experienced a pneumothorax.Chest tube was placed on (b)(6) 2025.Investigation is ongoing.
Event or Problem Description
On (b)(6) 2025, the patient received valve placement and experienced a pneumothorax.Chest tube was placed on (b)(6) 2025.Patient discharge (b)(6) 2025.Chest tube removal occurred on (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: 700 chesapeake drive; redwood city, CA 94063
• MDR Report Key: 23618489
• Report Number: 3007797756-2025-00062
• Device Sequence Number: 21095252
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)507218V70(17)270530
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 VALVE 4.0
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 507218-V7.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown