The patient had four zephyr valves implanted in the left lower lobe on (b)(6) 2022.The patient then developed a pneumothorax and a chest tube was placed on (b)(6) 2022.The patient had continuous air leak on suction on (b)(6) 2022.The 4.0-lp valve located in lb9 was removed on (b)(6) 2022, with the air leak becoming intermittent.A chest x-ray showed persistent pneumothorax on the left.The air leak suddenly became continuous and a second chest tube was placed.The patient became hypoxemic, was intubated, was started on bag valve ventilation, then had bradycardia and underwent cardiac arrest.During the cardiac arrest, a spontaneous pneumothorax in the right side occurred, and a third chest tube was placed.The patient then passed away.No autopsy was performed.The doctor's narrative regarding the cause of death: "valve attribution may be due to increased pressure upon intubation causing contralateral spontaneous pneumothorax.However, contralateral pneumothorax may be explained by the patient's advanced emphysema and bag ventilation after emergent intubation as well as chest compression during acls alone.".
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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.
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