Pleural effusion is a known, anticipated 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).In the liberate study (ide clinical study used to support pma (b)(4) approval), 7.0% of the zephyr valve subjects and 0% of the control subjects experienced pleural effusion during the treatment period (less than or equal to 45 days).The zephyr ebv system ifu specifically references pleural effusion as a known side effect of this procedure.The reported event aligns with the experience observed in the liberate clinical study and is an expected side effect of the zephyr valve treatment.The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.
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On (b)(6) 2021, the patient underwent a bronchoscopic lung volume reduction procedure with three zephyr valves implanted in the right upper lobe.The post-procedure x-ray showed a loculated effusion.The patient had another bronchoscopy procedure to clear secretions on (b)(6) 2021.On (b)(6) 2021, the patient had a ct scan to address the effusion and 2 chest drains were placed.After resolution, both chest drains were removed on (b)(6), 2021 and patient was discharged on (b)(6) 2021.
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