MAUDE Adverse Event Report: PULMONX, CORP ZEPHYR ENDOBRONCHIAL VALVE; VALVE, PULMONARY

Model Number	EBV-TS-5.5-LP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Valve did not load onto the deployer properly.Stuck out of deployer half deployed.Unable to use valve.Did this for 2 valves.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Common Device Name: VALVE, PULMONARY
• Manufacturer (Section D): PULMONX, CORP; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 22728371
• Report Number: 22728371
• Device Sequence Number: 8344996
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)507301V70(17)270815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2025
• Report Date (Section F): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EBV-TS-5.5-LP
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 507301V70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Date Report Sent to FDA: 07/28/2025