The patient had a bronchoscopic lung volume reduction procedure with four zephyr valves implanted in the left upper lobe (lul) on (b)(6) 2020.The patient developed a pneumothorax on (b)(6) 2020 requiring chest tube insertion.The chest tube was removed after 4 days on (b)(6) 2020, and the patient was discharged on (b)(6) 2020.On (b)(6) 2020, the patient experienced recurrence of shortness of breath during outpatient follow-up.Chest x-ray showed a thin-walled cavitary lesion with an air-fluid level.Computed tomography performed during hospital admission showed a partially fluid-filled bulla in the lul.A chest tube was placed, which resulted in a high flow air leak that failed to resolve after seven days of indwelling time and application of a blood patch.The patient was discharged with a heimlich valve on (b)(6) 2020.On (b)(6) 2020, the patient developed severe subcutaneous emphysema which was treated with wound vac placement.After discussion with the patient, all valves were removed on (b)(6) 2020.The chest tube migrated, was removed on (b)(6) 2020, and the patient was stable.The patient was discharged on (b)(6) 2020.
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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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