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 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 was a (b)(6) male who had been diagnosed with severe emphysema and was considered to be a candidate for bronchoscopic lung volume reduction (blvr) with the zephyr valves.His pulmonary function tests were notable for severe hyperinflation with residual volume 207% predicted, his 6mwd was 424 meters, he did not retain carbon dioxide and his resting room air pao2 was 79, and his tte revealed normal lv and rv size and function without evidence of pulmonary hypertension.On (b)(6) 2019, the patient was taken to the bronchoscopy room and chartis analysis showed a lack of collateral ventilation in the right upper lobe (rul).Therefore the right upper lobe was selected for lobar occlusion.Blvr was completed with placement of 4.0 ebv in rb-1 and rb 2 and a 5.5 ebv in rb3 with excellent results.Immediately post-procedure, chest x-ray (cxr) upon arrival to the recovery area showed a large right pneumothorax.A 14 french pigtail chest drain was placed with immediate improvement.There was a sizeable continuous air leak and the cxr showed the rul to be completely atelectatic with residual pneumothorax involving the right upper hemithorax.On pod (post-operative day) #1 ((b)(6) 2019), chest x-ray showed a continued right apical pneumothorax and a developing right-sided infiltrate, felt to be re-expansion pulmonary edema given rapid onset (first visible on initial re-expanded chest film following pigtail placement on pod #0, no fever, no cough/sputum).The patient had an increasing oxygen requirement.On pod #2 early morning, his pigtail catheter was temporarily occluded due to change in body position and he developed severe respiratory distress and worsening hypoxemic respiratory failure.He was transferred to the medical intensive care unit and placed on high flow oxygen (60 lpm, 100%, optiflow¿).Infiltrate involving the right lower lobe had worsened, and he had developed acute kidney injury.Later in the day pod (post-operative day) #2 ((b)(6) 2019), he suffered a sudden respiratory arrest and was found to have a tension pneumothorax on the left for which a surgical chest tube was placed.He required intubation during this event and subsequently developed significant shock (norepi infusion rapidly uptitrated to 40-50 mcg/min).Bronchoscopy showed purulent secretions which eventually grew streptococcus pneumoniae.He declined despite antibiotics, mechanical ventilation, and vasoactive infusions, requiring institution of vv ecmo (veno-venous extracorporeal membrane oxygenation) on the evening of pod #2.Shock was initially responsive to fluids, but on pod #3 ((b)(6) 2019) he had worsening distributive shock despite the above measures and ecmo support.The patient and family decided to cease further efforts and approached the team about comfort care in the evening of pod #3.The patient, who was lucid and arrived to this decision with his family's support, was transitioned to comfort care and died shortly thereafter on pod #3 ((b)(6) 2019).A postmortem examination was not done.The cause of death was progressive multisystem organ failure due to septic shock due to pneumococcal pneumonia.

• 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: 9491269
• MDR Text Key: 171955060
• Report Number: 3007797756-2019-00205
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030324
• UDI-Public: (01)00811907030324(10)504526V70(17)210907
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: ZEPHYR 5.5 EBV
• Device Catalogue Number: EBV-TS-5.5
• Device Lot Number: 504526-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2019
• 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: 65 YR
• Patient Weight: 74