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

Model Number	ZEPHYR 5.5 EBV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Death
Event or Problem Description
A blvr procedure was completed including implantation of four valves on (b)(6) 2025.The patient was transferred to icu post-procedure and the valves were removed in the following days after the procedure.It was made aware on (b)(6) 2025 that the patient had passed away while in recovery.
Event or Problem Description
A blvr procedure was completed including implantation of four valves (one valve in the right middle lobe (rml) and three in the right upper lobe (rul) on (b)(6) 2025.Per the physician, the procedure duration lasted for about one hour.On (b)(6) 2025, all four valves were explanted due to a decline in the patient's respiratory status following the procedure while in the icu.The valves remained implanted for a total of 3 days.On (b)(6) 2025, immediately following the bronchoscopy, the patient experienced a failed extubation due to co[?] retention and hypersomnolence, requiring re-intubation and transfer to the icu.Despite various ventilator adjustments, the patient demonstrated very poor air movement.The valves were removed after three days; however, the patient's condition did not improve.The patient continued to deteriorate and subsequently passed away on (b)(6) 2025.Per the medical chart, the following statement was documented: "due to persistence of ventilator dependence and inability to wean patient successfully from paralysis and deep sedation, counseled family that next treatment option was to undergo tracheostomy placement versus pursue comfort focused care.In speaking with mr.(b)(6) family, they relayed that tracheostomy was not in line with his goals of care.As such, patient was transitioned to comfort focused care on (b)(6) 2025 and was palliatively extubated at this time.Mr.(b)(6) passed peacefully shortly thereafter on (b)(6) 2025 at 20:30." according to the patient's chart and medical records, the primary cause of death was acute hypoxemic hypercapnic respiratory failure attributed to severely limited pulmonary reserve and the effects of general anesthesia.A secondary contributing factor was a copd exacerbation.No autopsy was performed.According to the physician, the valves were discarded as they were not believed to be related to the patient's clinical deterioration or cause of death.

• 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: 21857674
• Report Number: 3007797756-2025-00022
• Device Sequence Number: 20014007
• Product Code: NJK
• UDI-Device Identifier: 00811907030324
• UDI-Public: (01)00811907030324(10)506906V80(17)260905
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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 Expiration Date: 09/05/2026
• Device Model Number: ZEPHYR 5.5 EBV
• Device Catalogue Number: EBV-TS-5.5
• Device Lot Number: 506906-V8.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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; Death
• Patient Age: 66 YR
• Patient Sex: Male