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

Model Number ZEPHYR 5.5 EBV

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

Patient Problem Pneumothorax (2012)

Event Date 11/13/2019

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, a (b)(6)-year old female, was evaluated for bronchoscopic lung volume reduction (blvr) with the zephyr valves for her severe emphysema.While the patient met the selection criteria, she fell into the category of patients who could experience a complex pneumothorax if one were to occur due to the destruction of the untreated lobe (per the stratx report) and past medical history.This risk and its management and consequences were carefully discussed with the patient prior to the blvr procedure.The patient understood these risks and still insisted that she wished to proceed.On (b)(6) 2019, the patient underwent the blvr procedure with placement of three zephyr valves (two 5.5 ebvs, one 5.5-lp ebv) in the left upper lobe.Approximately 30 minutes following valve placement, the patient experienced a pneumothorax and a chest tube was placed without complications.Post-procedure management was per the hospital's institutional protocol and patient was administered heparin prophylactically to prevent deep vein thrombosis ( post operative day #1).The pneumothorax was resolving; patient was otherwise stable.During the night, the patient experienced a strong episode of cough and developed a larger pneumothorax.The previously placed chest tube was placed on negative 40 suction and was tapered over time.Daily chest x-rays indicated that the pneumothorax was resolving and the air leak was slowing.However, as the air leak persisted for a number of days, the physician proposed removal of one valve to allow for re-expansion of the treated lobe and resolution of the air leak.However, the patient refused.The patient did not want to have any valves removed despite the pneumothorax.The patient was ambulatory and reported feeling much better than she did prior to valve placement.The patient's persistent air leak had been healing, slowly but consistently, and the amount of suction had been reduced significantly (down to water seal on the chest tube).The plan was to discharge the patient, possibly on a heimlich valve.However, during the night of (b)(6) 2019, the patient developed new/increased shortness of breath, and showed marked oxygen desaturation.Assessments including ct revealed that the patient had a pulmonary embolism in the right lung (not the treated lobe).The patient was already receiving subcutaneous lovenox so the patient was treated with tissue plasminogen activator (tpa) to address the clot and started on a heparin drip.The patient was intubated and placed on mechanical ventilation.On the morning of (b)(6) 2019, one zephyr 5.5 ebv that had been placed in the lingula was removed; this allowed the lobe to reflate and increased the patient's oxygenation level.The plan was to replace the valve in the lingula in approximately 3 months, once the patient had fully recovered.As of (b)(6) 2019, the patient was considered stable and comfortable, and was to remain hospitalized until it could be determined that the pulmonary embolism was no longer a risk.The patient was extubated.However during the early hours of (b)(6) 2019, the patient again experienced desaturation and compromised cardiac function, which was determined to be due to a second pulmonary embolus in the right lung with possible bleeding as well based on lab work.The patient was again intubated and mechanically ventilated, and eventually progressed in to cardiac arrest.Immediately after, cpr was initiated.With further discussion with the family, the patient's family decided not to pursue further intervention, and as a result, the patient expired on (b)(6) 2019.The family did not want to have an autopsy.Based on the fact that the pulmonary emboli were on the right, untreated lung, the physician believes that the embolism was not related to the placement of the zephyr valves.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: leland keyt ; 700 chesapeake drive; redwood city, CA 94063 ; 6502160144
• MDR Report Key: 9460045
• MDR Text Key: 170522805
• Report Number: 3007797756-2019-00197
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030324
• UDI-Public: (01)00811907030324(10)504384V70(17)210523
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: ZEPHYR 5.5 EBV
• Device Catalogue Number: EBV-TS-5.5
• Device Lot Number: 504384-V7.0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 83