MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0 LP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2023

Event Type  Death  

Event Description

The patient had an endobronchial valve procedure.The patient passed away post procedure.More information will be provided when available.

Event Description

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.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Type of Device: 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: 18307051
• MDR Text Key: 330220566
• Report Number: 3007797756-2023-00220
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030225
• UDI-Public: (01)00811907030225(10)506528V71(17)241117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZEPHYR 4.0 LP
• Device Catalogue Number: EBV-TS-4.0-LP
• Device Lot Number: 506528-V7.1
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death