MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number ZEPHYR 4.0 EBV

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

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012)

Event Date 05/23/2022

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.

Event Description

The patient had a bronchoscopic lung volume reduction procedure with three zephyr valves placed in the left upper lobe on (b)(6) 2022.The procedure was very uneventful.Chest x-rays done later in the afternoon showed a left pneumothorax and a chest tube was placed.Over the next several days, the patient was monitored in the icu and in general was stable with the chest tube and small air leak.There was no significant change in her vitals or oxygenation.On may 22, 2022, the patient complained of an upset stomach, however there was no change in overall status.On may 23, 2022 at around 4 am, a week after procedure, the patient went into acute cardiopulmonary arrest with initial rhythm being pea (pulseless electrical activity).Patient still had the chest tube and the air leak remained the same.Upon intubation, the patient was found to have a large amount of secretions, possibly from stomach content.After more than 30 minutes with no pulse regained, cpr was terminated and the patient was pronounced dead.According to the treating physician, it is not very clear as to what might have caused the cardiopulmonary arrest, however, it is very possible that she had large vomit and large volume aspiration based on the description of events above.Another possibility is a cardiac event.According to the treating physician, there is no evidence to suggest that endobronchial valves had anything to do with the death.No autopsy was performed.

• 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: 14749728
• MDR Text Key: 294376302
• Report Number: 3007797756-2022-00169
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030126
• UDI-Public: (01)00811907030126(10)505663V70(17)230609
• 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
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: ZEPHYR 4.0 EBV
• Device Catalogue Number: EBV-TS-4.0
• Device Lot Number: 505663-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female