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

Model Number ZEPHYR 5.5-LP EBV

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

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012); Septic Shock (2068)

Event Date 11/12/2020

Event Type  Death  

Manufacturer Narrative

Initial mdr 3007797756-2021-00161 was submitted on july 16, 2021 with no product/lot information or event description.This mdr provides lot information for one of the products used.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

The patient had four zephyr valves implanted in the right middle and right upper lobes on (b)(6) 2020.The procedure was complicated by postoperative pneumothorax requiring a right-sided chest tube and thoracic vent.On (b)(6) 2020, the patient was doing well.He was up and about and talking all day.A chest x-ray showed stable chest tube without evidence of pneumothorax.At around 11:00pm, the patient had a coughing episode and received lidocaine and tessalon perles for the cough, he then immediately complained about shortness of breath and swelling of the throat.The patient also was noted to have subcutaneous emphysema on the right side of the chest.The patient was transferred to the icu where he was alert, awake, and had a hoarse voice but was able to swallow his saliva and could talk in complete sentences.The patient stated that his throat felt swollen but it was not getting worse.His tongue and lips were not swollen.The patient was treated with decadron 10 mg iv x1 along with racemic epi nebulization (nebulization scheduled every 4 hours) and pepcid iv and the patient was counseled that if his throat got worse with more swelling he would require intubation and mechanical ventilation.This happened and as the patient was having difficulty swallowing his saliva, he was intubated to protect the airway.On (b)(6) 2020, the patient self-extubated during the night, was worsening and had to be reintubated.His leukocytosis was worsening, and levaquin was administered to treat the infection.On (b)(6) 2020 the patient was slightly tachypneic on ventilation; sedation was increased.There was a continued air leak in the right chest tube and an exploratory bronchoscopy was planned but could not get an ng or og tube down.On (b)(6) 2020 the patient experienced worsening renal function and renal consultation was sought.A bronchoscopy was performed and the pulmonologist noted that she "saw a valve in the lul".Another bronchoscopy was performed the following day.All valves were found to be in the correct position "rml and rul valves are well situated however the lul appears very inflamed and mucosal bleeding noted".However, due to concerns from the previous day's bronchoscopy, it was decided to take the rml valve out even though it was in optimal position.On (b)(6) 2020, the creatinine was worsening, and potassium levels were slightly elevated.However, the patient was starting to make some urine.Patient was being assessed by both renal and pulmonary and radiology was consulted since the right sided pneumothorax was still present (mild).Patient was not ready for extubation.His oxygenation got worse on (b)(6) 2020 as did his urine output.Wbc had increased to 29 and patient was experiencing worsening septic shock.Pressor requirements were increasing, ph was 6.83, so a bicarb drip was started.Patient deteriorated very quickly; however, the repeat x-rays were not showing worsening of pneumothorax.The patient's wife was informed of his condition including a high rate of deterioration leading to cardiac arrest as he was not able to maintain oxygenation above 80% despite 100% fio2; she was at the bedside and requested that team remain on full code till her other family members arrive.Sadly, the patient went into cardiac arrest.Cpr was administered but there was no return to spontaneous circulation and the patient was pronounced dead at 6:04 am on (b)(6) 2020.No autopsy was performed.In summary, the cause of death was listed as cardiac arrest.

• 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: mahtab fatemi ; 700 chesapeake drive; redwood city, CA 94063 ; 6504072823
• MDR Report Key: 12662153
• MDR Text Key: 277594833
• Report Number: 3007797756-2021-00294
• Device Sequence Number: 1
• Product Code: NJK
• UDI-Device Identifier: 00811907030423
• UDI-Public: (01)00811907030423(10)505035V70(17)220605
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: ZEPHYR 5.5-LP EBV
• Device Catalogue Number: EBV-TS-5.5-LP
• Device Lot Number: 505035-V7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR