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

Model Number ZEPHYR 5.5-LP

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

Patient Problems Death (1802); Pneumothorax (2012)

Event Date 11/18/2019

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 ((b)(6)).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 ((b)(6)).Am j respir crit care med.2018; 198 (9): 1151-1164).In the (b)(6) study ((b)(6) 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 (b)(6) clinical study and is an expected side effect to the zephyr valve treatment.

Event Description

The patient underwent endoscopic lung volume reduction on (b)(6) 2019.She had two valves placed in the right upper lobe and right middle lobe, respectively.She had complete occlusion of her airways and developed a pneumothorax which was discovered in the pacu.She then had a small bore chest tube placed in the right anterior wall and into the pleural space.Her pneumothorax recovered but then after the chest tube was removed approximately 8 hours later, she had a coughing fit after eating potatoes, and developed a new pneumothorax.A second chest tube was then placed and she was discharged home on waterseal to a dry mini atrium.The patient had a repeat chest x-ray on (b)(6) 2019 as well as (b)(6) 2019.On (b)(6) 2019, the patient had no serious complaints except for the chest tube discomfort and wanting the chest tube removed.She still was sleeping poorly.The chest tube was removed without incident.A follow-up chest x-ray was completed which demonstrated no pneumothorax.She was discharged home to follow-up with her primary pulmonologist and a follow-up appointment in a week.On (b)(6) 2019, she was admitted to the hospital with a left lower lobe pneumonia (the non-treated lobe).She developed severe septic shock with multiorgan fight failure.Final ct scan from (b)(6) 2019 demonstrated a left lower lobe pneumonia and stable placements of the zephyr valves in the right upper and right middle lobe.Signs of emphysema and bullous disease were present.There were some mild infiltrates on the right side but not in the treated right middle lobe and right upper lobe subsegments.The patient unfortunately had recalcitrance metabolic acidosis renal failure liver failure and lactic acidosis >20.She was made dnr by her family and died on (b)(6) at 2:28am.The pulmonary doctor stated that "this tragic and untimely death is not related the elvr or the zephyr valves.The patient was on immunosuppressive therapy and was unable to mount any significant response to infection despite efforts by the icu team.".

• 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: 9496431
• MDR Text Key: 172031704
• Report Number: 3007797756-2019-00210
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)504434V70(17)210708
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: ZEPHYR 5.5-LP
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 504434-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2019
• 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