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	Pneumothorax (2012)
Date of Event	02/04/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Pneumothorax is the most common 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).Targeted lobar deflation likely causes inflation of the ipsilateral lobe, which can result in a tear of the already compromised parenchymal tissue of the emphysematous ipsilateral lobe, resulting in a pneumothorax (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), 26.6% of the zephyr valve subjects experienced a pneumothorax in the treatment period ([less than or equal to 45 days).These were managed using standard of care procedures as per previously published guidelines (valipour, arschang, et al.Respiration 87.6 (2014): 513-521).In 17.4% of the events, the pneumothorax resolved without any additional intervention with subjects under careful observation.In over half the events (56.5%), the pneumothorax was managed with a chest-tube only.An additional 13% of the events were managed with a chest-tube and the temporary removal of one or more valves, while another 13% of the events were managed with a chest-tube and removal of all the implanted valves.Upon successful resolution of the pneumothorax, removed valves can be replaced.Patients that experienced a pneumothorax experienced clinical benefits of the zephyr valve treatment that were similar to the benefits experienced by patients who did not have a pneumothorax.The zephyr ebv system ifu and pulmonx training program both specifically reference pneumothorax as a known side effect of this procedure and the published guidelines (valipour, arschang, et al."expert statement: pneumothorax associated with endoscopic valve therapy for emphysema-potential mechanisms, treatment algorithm, and case examples." respiration 87.6 (2014): 513-521).The reported event aligns with the experience observed in the liberate clinical study and is an expected side effect to the zephyr valve treatment.
Event or Problem Description
Patient was a 72-year old female with a history of copd, chronic hypoxic respiratory failure, atrial fibrillation, coronary artery disease (cad), hypertension (htn), diabetes mellitus (dm), gerd, hypothyroidism, anxiety/depression, and obesity (bmi 31).She was evaluated for blvr and underwent a valve placement procedure on (b)(6) /2024.The procedure was completed with placement of two zephyr valves in the left upper lobe (lb1/lb2/lb3 - 5.5-lp; lb4/lb5 - 4.0-lp).The patient was kept in icu overnight then transferred to stepdown floor.No issues during stay.The patient was discharged home on (b)(6) 2024.She was doing great at home and shortness of breath had significantly improved.On (b)(6) 2024 she went to the restroom and had a "coughing fit" and then started to swell up.She was taken to local er where chest tubes were placed for a pneumothorax and subsequent severe subcutaneous air.Eventually she was intubated and then transferred to the treating hospital.She was extubated on (b)(6) 2024.The small-bore chest tube #1 was removed on (b)(6) 2024.Large bore chest tube #2 was removed on (b)(6) 2024 after being on water seal for days.She had some anemia but no obvious bleeding.Her eliquis was held for a few days.Prbc x1 was given.She developed significant delirium which was treated conservatively.She was transferred from icu to tele floor.That night around 4:00am there was a report of decreased level of consciousness (loc).Rapid response was called.Chest x-ray done and showed stable subcutaneous air but no pneumothorax.Chest tube was placed at bedside.Cpr was initiated and done for 30 min without return of spontaneous circulation (rosc).The patient died on (b)(6) 2024.An autopsy was not performed.The treating physician's opinion is that the event was related to the valves but not the immediate cause of death.This information is sourced from the hospital emr chart.

• 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: 18914770
• Report Number: 3007797756-2024-00021
• Device Sequence Number: 6893011
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)506801V70(17)260602
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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: 06/02/2026
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 506801-V7.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female