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

Model Number ZEPHYR 4.0-LP EBV

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

Patient Problem Pneumothorax (2012)

Event Date 09/06/2019

Event Type  Injury  

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

On (b)(6) 2019, the patient underwent a bronchoscopy procedure and assessment with the chartis system to determine collateral ventilation (cv) status.The patient was eligible for valves in the left upper lobe (lul) based on cv assessment (cv negative).A total of five zephyr valves (4.0 ebv and 4.0-lp ebvs) were placed in the lul.Patient did well post procedure and was transferred to a monitored floor.A day after the procedure ((b)(6) 2019), the patient developed sudden onset shortness of breath and increasing oxygen requirements and was diagnosed with a left-sided pneumothorax.A small bore (14 fr) chest tube was placed with immediate improvement in her symptoms and oxygenation.Daily chest x-rays were obtained and once the air leak decreased along with lung expansion, a pneumostat was attached.The patient was monitored for 2 additional days in the hospital with the pneumostat, and daily chest x-rays revealed continued lung expansion.The patient was discharged home on (b)(6) 2019 and complete resolution of air leak and complete radiographic lung expansion occurred around day 9 post discharge from the hospital.On a follow up visit, patient reported significant improvement in her dyspnea symptoms and remains active at home.The plan is to remove her chest tube at the time of the next follow-up visit.

• 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: 9159251
• MDR Text Key: 165761378
• Report Number: 3007797756-2019-00127
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• 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: ZEPHYR 4.0-LP EBV
• Device Catalogue Number: EBV-TS-4.0-LP
• Device Lot Number: 504402-V7.1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65