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

Model Number EBV-TS-4.0-LP

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 06/02/2020

Event Type  Death  

Manufacturer Narrative

This severe emphysema patient with proven coronary artery disease (cad) died shortly after sudden onset of shortness of breath despite resuscitation efforts.No autopsy was performed.Based on the cad, emphysema history, and the physician's narrative, cardiopulmonary arrest likely occurred although without an autopsy the exact cause of death remains uncertain.Based on the physician's narrative, the patient possibly experienced a pneumothorax although without an autopsy this cannot be confirmed.Since a pneumothorax event possibly occurred, an assessment of this complication is included below.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 suspected 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, a (b)(6) male with a history of copd/emphysema and coronary artery disease that was medically managed (20-30% lad disease only diagnosed in 2018) and no symptoms.Patient had an ejection fraction of 45% assessed by transthoracic echocardiogram (within normal limits).Patient underwent a zephyr valve placement procedure on (b)(6) 2020 with 2 valves in the right upper lobe and 2 valves in the right middle lobe.Patient tolerated the procedure well and had an unremarkable recovery; atelectasis of the treated lobe (based on daily chest x-rays) was occurring and there was subjective improvement during hospital stay.He continuously stated he felt like an elephant had been lifted off of his chest.Post-procedure management included bed rest and bronchodilator on the day of the procedure, with patient out of bed and on chair on post-procedure day 1, and able to walk around the room and hallways on post-procedure day 2.Patient was feeling incredibly well (on "cloud nine" per patient) and was discharged to home on sunday (b)(6) 2020, day 5 post-elvr.The nurse coordinator contacted the patient daily by phone and also talked to the patient's daughter on the day of death.He was off his oxygen, running errands and "walking tall".He was so happy with his results.Patient was feeling fantastic, had no shortness of breath and barely any dyspnea on exertion.Patient felt that he did not need to use his oxygen.The patient was reminded by the nurse coordinator about the risk of a pneumothorax, the symptoms of a pneumothorax and what to do.During the call on tuesday, (b)(6) 2020, the patient was given instructions for follow-up appointment later in the week with the treating physician.On tuesday night ((b)(6) 2020), he had sudden onset shortness of breath.His daughter who lives next door and checked on the patient daily called ems, but ems was unable to save the patient who had arrested and died at home.No autopsy was performed.It is possible that the patient may have experienced a pneumothorax related to the zephyr valve procedure, although without an autopsy this cannot be confirmed.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city, ca
• Manufacturer Contact: leland keyt ; 700 chesapeake drive; redwood city, ca ; 2160144
• MDR Report Key: 10172067
• MDR Text Key: 195779523
• Report Number: 3007797756-2020-00131
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030225
• UDI-Public: (01)00811907030225(10)504402V71(17)210612
• 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: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: EBV-TS-4.0-LP
• Device Lot Number: 504402-V7.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• 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): Death; Required Intervention
• Patient Age: 66 YR