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

Model Number ZEPHYR 5.5-LP EBV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adult Respiratory Distress Syndrome (1696); Atrial Fibrillation (1729); Cyst(s) (1800); Pneumothorax (2012); Renal Failure (2041); Bronchospasm (2598); Wheezing (4463)

Event Date 04/27/2021

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(b)(4)'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

Patient had zephyr valves implanted in the right upper lobe (rul) and right middle lobe (rml) on (b)(6) 2021.An x-ray immediately after the procedure showed no atelectasis or pneumothorax.On (b)(6) 2021, the patient had stridor and was re-intubated, with no change visible on a chest x-ray.On (b)(6) 2021, the patient was more breathless than baseline, venous blood gas (vbg) levels were acceptable; and the patient was put on antibiotics for infection.On (b)(6) 2021, the patient was still breathless.The patient underwent a bronchoscopy to inspect the valves and both the rul apical valve and rml rb4a valve were seen to be leaking air.Both were removed and replaced with new valves.A chest x-ray immediately after the procedure showed some atelectasis; the endotracheal tube was removed 8 hours later.On (b)(6) 2021, the patient developed a pneumothorax and was having bronchospasms.A chest tube was placed.On (b)(6) 2021 the patient showed infiltrate in the untreated right lower lobe.The patient was feeling a little better on (b)(6) 2021.A ct scan showed a large cyst along the fissure distal to the valves.On (b)(6) 2021, the patient underwent another bronchoscopy to remove all of the valves; valves were sent to pathology.The patient has a hydropneumothorax and is on tpa.On (b)(6) 2021, the patient was showing signs of kidney failure.The event was ongoing as of (b)(6) 2021, as far as pulmonx is aware.Pulmonx is awaiting additional information from the treating physician.

Event Description

The patient, a 66 year old female, had zephyr valves implanted in the right upper lobe (rul) and right middle lobe (rml) on (b)(6) 2021.Procedural observation was that the airways were floppy consistent with severe excessive dynamic airway collapse (edac).An x-ray immediately after the procedure showed no atelectasis or pneumothorax.On (b)(6) 2021, the patient had post-extubation stridor and was reintubated, with no change visible on a chest x-ray.She was extubated the next day.On (b)(6) 2021, the patient was more breathless than baseline, venous blood gas (vbg) levels were acceptable; and the patient was put on antibiotics for infection.The patient was put on a high flow nasal cannula on (b)(6) 2021.On (b)(6) 2021, the patient was still breathless and a bronchoscopy was performed to inspect the valves.Both the rul apical valve and rml rb4a valve were seen to be leaking air.Both valves were removed and replaced with new valves.A chest x-ray immediately after the procedure showed some atelectasis; the endotracheal tube was removed but she failed extubation within an hour so reintubated.Cxr revealed a right pneumothorax and a chest tube was placed.She was never liberated from mechanical ventilation from that point forward.Bronchospasms noted and steroids begun.On the evening of (b)(6) 2021, the patient developed atrial fibrillation with rapid ventricular response.On (b)(6) 2021 the patient showed infiltrate in the untreated right lower lobe.The patient was feeling a little better on (b)(6) 2021.A ct scan showed a large cyst along the fissure distal to the valves.On (b)(6) 2021, the patient developed hemoptysis.A ct scan showed a loculated right posterior hydropneumothorax.A pigtail catheter was placed and chest tubes were put to suction.On (b)(6) 2021, the patient underwent another bronchoscopy to remove all of the valves.Loculated hemopneumothorax was addressed with intracavitary tpa.On (b)(6) 2021, the patient was re-bronched.On (b)(6) 2021, the patient still had a significant, ongoing leak.The patient started developing acute kidney injury on (b)(6) 2021 and was put on renal replacement therapy.The patient never woke up normally after sedation and a head ct showed no acute stroke.A dobbhoff tube was placed for nutrition.The patient's family was contacted and decided on palliative care therapy.The patient was extubated and passed away on (b)(6) 2021.

Manufacturer Narrative

According to the treating physician: "the proximal cause of death was related to valve implantation.We were unaware of the severity of her edac".The death seems related to zephyr valves placement successive complications in a clinical setting of acute respiratory distress syndrome.

• Brand Name: ZEPHYR ENDOBRONCHIAL VALVE (EBV)
• Type of Device: ENDOBRONCHIAL VALVE
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 11902630
• MDR Text Key: 266835055
• Report Number: 3007797756-2021-00110
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)505154V70(17)220903
• Combination Product (y/n): N
• PMA/PMN Number: P180002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 505154-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 66 YR