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 Codes	Hemothorax (1896); Respiratory Failure (2484)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Respiratory failure is an anticipated, potential side effect associated with the zephyr valve treatment (criner et al.A multicenter randomized controlled trial of zephyr endobronchial valve treatment in heterogeneous emphysema (liberate).Am j respir crit care med.2018; 198 (9): 1151-1164).In the liberate study (ide clinical study used to support pma p180002's approval), 1.6% of the zephyr valve subjects experienced respiratory failure during the treatment period ([less than or equal to 45 days).0.8% of the zephyr valve subjects and 3.2% of the control subjects experienced respiratory failure during the longer-term period from 45 days after the study procedure through 12 months post-procedure.The zephyr ebv system ifu and pulmonx training program both specifically reference respiratory failure as a known side effect of this procedure.The reported event aligns with the experience observed in the liberate clinical study and is an anticipated, potential side effect to the zephyr valve treatment.The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.
Event or Problem Description
The patient had a bronchoscopic lung volume reduction revision procedure with three zephyr valves placed in the left upper lobe on (b)(6) 2021.The patient had a pneumothorax which was previously reported in mfr.Report #s 3007797756-2022-00124, 3007797756-2022-00125, and 3007797756-2022-00126 in (b)(6) 2022.This report is being submitted to document subsequent adverse events that were not included in the prior reports.On (b)(6) 2021, the patient was re-admitted to the hospital for respiratory distress, requiring drainage of a left lung hemothorax.The hemothorax was resolved on (b)(6)2021.The patient experienced respiratory failure on (b)(6) 2022 and was readmitted to a hospital and diagnosed with ongoing respiratory distress requiring oxygen therapy.He was started on iv steroids.Patient was transferred for admission to the treating hospital on (b)(6) 2022 for consideration of ebv removal, and removal of all valves was done on (b)(6) 2022.After the procedure, patient reported improvement in shortness of breath.Steroids were weaned to prednisone (40mg daily).On (b)(6) 2022, the respiratory failure was resolved.The patient was discharged from the hospital on jan.9, 2022 and instructed to follow-up with a pulmonologist.

• 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: 18743607
• Report Number: 3007797756-2024-00009
• Device Sequence Number: 6380791
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)505288V70(17)221112
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 11/12/2022
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 505288-V7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• 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; Required Intervention
• Patient Sex: Unknown