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

Model Number ZEPHYR 5.5-LP EBV

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

Patient Problems Atrial Fibrillation (1729); Pneumonia (2011); Pneumothorax (2012); Sepsis (2067); Respiratory Failure (2484)

Event Date 06/01/2021

Event Type  Death  

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.Pneumonia 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), 0.8% of the zephyr valve subjects vs.0% of the control subjects experienced a pneumonia serious adverse event (sae) during the treatment period (less than or equal to 45 days).5.7% of the zephyr valve subjects vs.8.1% of the control subjects experienced a pneumonia sae 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 pneumonia as a known, potential side effect of this procedure and provide guidelines for monitoring.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 Description

On (b)(6) 2021, patient was brought in for the scheduled bronchoscopic lung volume reduction (blvr) procedure.The physician noted heavy secretions during the bronchoscopy and did not continue with valve placement.Patient came back on (b)(6) 2021 and had 3 zephyr valves placed in the left upper lobe.A pneumothorax presented on first chest x-ray on 06-01-2021.A chest tube was inserted and as of the last communication on 06-22-2021, the patient has remained in the hospital and was on a ventilator.The pneumothorax resolved (the exact date unknown), but the chest tube was still in place due to the ventilator.The patient was reported to also have pneumonia.The details regarding the pneumonia, e.G., dates/duration, location (e.G., left lung, right lung, distal/proximal to valves), severity, treatment, were requested but have not yet been provided.A follow-up report will be submitted once additional information is obtained.

Event Description

On (b)(6) 2021, patient was brought in for the scheduled bronchoscopic lung volume reduction (blvr) procedure.The physician noted heavy secretions during the bronchoscopy and did not continue with valve placement.Patient came back on (b)(6) 2021 and had 3 zephyr valves placed in the left upper lobe.A left-sided pneumothorax presented on first chest x-ray 15 minutes after the procedure on (b)(6) 2021.The patient was hypoxemic at that time (85% on 6 lpm).A chest tube was inserted immediately with re-expansion of the left lung.The patient was admitted to the icu for further management.He remained on supplemental oxygen.On (b)(6) 2021, the patient had respiratory deterioration with worsening of left pneumothorax and development of extensive pneumomediastinum.He was emergently intubated and the left chest tube was replaced with a larger bore chest tube.A bronchoscopy was performed and the lb3 valve was removed the same day.Thoracic surgery was consulted and performed gill's procedure to treat his pneumomediastinum.His condition continued to improve for a few days but a few days later, he developed severe b/l pneumonia,likely ventilator-associated pneumonia.Afterwards, he developed progressive respiratory failure and continued to deteriorate despite maximum medical therapy.His clinical course was further complicated by development atrial fibrillation with rapid ventricular rate and sepsis.Due to his progressive decline, his family eventually decided to change his code status to comfort care dnr, remove the ventilator and let him pass naturally.The patient died on (b)(6) 2021.No autopsy was performed.While the initial decline in his condition was due to pneumothorax caused by bronchoscopic lung volume reduction, his progressive respiratory failure and demise was due to development of ventilator associated pneumonia and associated sepsis.The cause of death recorded in the medical chart was "acute respiratory failure, sepsis, ventilator associated pneumonia and atrial fibrillation".The internal investigation by a medical doctor concluded the death was not related to the valves or procedure.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 12100302
• MDR Text Key: 260936170
• Report Number: 3007797756-2021-00142
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)505066V70(17)220624
• Combination Product (y/n): N
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 505066-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 70