MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number	ZEPHYR 5.5 LP EBV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2023
Type of Reportable Event	Death
Event or Problem Description
This is a follow up report related to the same mdr event already included in the following report number submitted to the fda: 3007797756-2023-00220.This report covers the additional device used in this case.Patient selected for valve therapy after pft, symptoms, perfusion scan and intra op balloon occlusion determined her to meet all criteria.Procedure performed on (b)(6) 2023 with 3 valves in rul.After procedure- no pneumothorax and complete atelectasis of the rul just as planned.Patient refused to exercise, let nurses move her and preferred to be bed bound in hospital.Therefore - she became nasal cannula dependent from basilar atelectasis and mucus impactions.Patient did not want to participate in airway clearance.Finally, she started telling team that her daughter forced her to have the valves and that she did not want the valves.The physician notes that this was not his experience in pre - procedure interviews and detailed prolonged work up.The patient claimed that she was more short of breath after procedure and she wanted valves out.This was during the time she was refusing all pt/ot and other therapies.Per the patient's wishes the valves were removed (b)(6) 2023 (i only know that the valves were removed 2 weeks after placement but the doctor did not provide the exact date) and she went to hospice where she passed away (b)(6) 2023 (again, the only info i was given was she died 2 weeks after the valves were removed while in hospice).We are unable to get the physician's perspective on the relationship of the death to the valves, but given the valves had been removed, the death is not likely to be related to the valves, but rather the poor conditioning of the patient.
Additional Manufacturer Narrative
This is a follow up report related to the same mdr event already included in the following report number submitted to the fda: 3007797756-2023-00220.This report covers the additional device used in this case.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Common Device Name: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: mahtab fatemi ; 700 chesapeake drive; redwood city, CA 94063 ; 6504072823
• MDR Report Key: 19174206
• Report Number: 3007797756-2024-00035
• Device Sequence Number: 20801767
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)506588V70(17)260120
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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
• Report Date (Section B): 04/22/2024

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 Expiration Date: 01/20/2026
• Device Model Number: ZEPHYR 5.5 LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 506588-V7.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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