Model Number ZEPHYR 5.5 EBV |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Pneumothorax (2012)
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Event Date 01/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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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), (b)(4) % 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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Event Description
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The patient had a bronchoscopic lung volume reduction procedure with zephyr valves placed in the left upper lobe on (b)(6) 2024.The patient had a complex pneumothorax on (b)(6) 2024 while still in the hospital, and a chest tube was placed on the same day.On (b)(6) , 2024, one valve was removed.During the valve removal procedure, the patient experienced cardiac arrest but was able to recover.After improvement, the chest tube was removed on (b)(6) 2024, and the pneumothorax was resolved by (b)(6) 2024.As of (b)(6) 2024 (the most recent update), the patient was still in the hospital improving.
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Manufacturer Narrative
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The initial mdr for this event was submitted in mfr report # 3007797756-2024-00019 on feb.23, 2024.Since the time of the initial report, additional product model information and hospital discharge date were provided and as such this follow-up report is being submitted.
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Event Description
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The patient had a bronchoscopic lung volume reduction procedure with zephyr valves placed in the left upper lobe on (b)(6)2022, 2024.The patient had a complex pneumothorax on (b)(6) 2024 while still in the hospital, and a chest tube was placed on the same day.On (b)(6) 2024, one valve was removed.During the valve removal procedure, the patient experienced cardiac arrest but was able to recover.After improvement, the chest tube was removed on (b)(6) 2024, and the pneumothorax was resolved by (b)(6) 2024.The patient was discharged from the hospital on (b)(6) 2024.
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Search Alerts/Recalls
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