MAUDE Adverse Event Report: PULMONX CORPORATION ZEPHYR ENDOBRONCHIAL VALVE

Model Number	ZEPHYR 5.5 EBV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/25/2023
Type of Reportable Event	Death
Event or Problem Description
The patient was a 77 year-old male diagnosed with severe copd/emphysema on chronic home oxygen and a number of comorbidities including polio without residual weakness, lumbar spinal stenosis, hypertension, hyperlipidemia, anxiety, and bph.The patient was suitable for bronchoscopic lung volume reduction with valves and underwent the procedure on (b)(6) 2023.Three zephyr endobronchial valves placed to the left upper lobe.During the procedure, secretions were noted within the airway which were collected as bronchial washing and sent for microbiologic analysis.Post procedure, the patient developed a large pneumothorax identified within 1 hour of procedure in the pacu with immediate insertion of 14 french pigtail catheter upon pneumothorax identification.He had a severe persistent air leak.He was then hospitalized to the internal medicine service however due to increasing oxygen requirements (up to 15 l non-rebreather) and severe dyspnea/tachypnea, he was transferred to the icu on (b)(6) 2023.He was started on as needed opioids as well as precedex infusion.His pneumothorax slightly worsened despite the single 14 french pigtail catheter and thus a 2nd 14 french pigtail catheter was placed by our interventional colleagues on (b)(6) 2023.Haemophilus influenzae was identified from bronchoscopy culture on this day and treatment was initiated.He decompensated overnight and was intubated on (b)(6) 2023.At this point, the decision was to remove the valves and the procedure was done at the bedside in the icu.All 3 zephyr valves were removed on (b)(6) 2023.After removal of the endobronchial valves, his tidal volumes increased in his air leak minimized.One of his chest tubes were removed on (b)(6) 2023.Around the same time, he also tested positive for streptococcus pneumoniae from his initial bronchoscopy, and he was treated based off of susceptibilities.During his icu course, he also developed cardiac arrhythmias including atrial fibrillation with rvr and svt.He was treated with amiodarone.He was extubated to bipap on (b)(6) 2023 though was reintubated on (b)(6) 2023 due to respiratory failure, encephalopathy, acute hypertension, and severe tachycardia with heart rates in the 200s.He remained in the icu and on (b)(6) 2023, a family meeting was performed, and comfort care measures were initiated.He died on (b)(6) 2023.No autopsy was performed.The cause of death was multifactorial including severe copd/emphysema, septic shock from haemophilus influenzae and streptococcus pneumonia, multifactorial encephalopathy, and large pneumothorax with severe air leak which resolved after valves were removed.The death was not directly related to the valves.The source used to detail the cause of death was the emr.
Additional 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.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE
• Common Device Name: 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: 18094333
• Report Number: 3007797756-2023-00201
• Device Sequence Number: 12429819
• Product Code: NJK
• UDI-Device Identifier: 00811907030324
• UDI-Public: (01)00811907030324(10)506740V71(17)231009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2023
• Device Model Number: ZEPHYR 5.5 EBV
• Device Catalogue Number: EBV-TS-5.5
• Device Lot Number: 506740-V7.1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Male