Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/31/2020 |
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), 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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Event Description
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On (b)(6) 2020, the patient had five zephyr valves implanted in the right upper lobe and right middle lobe.On (b)(6) 2020, the patient experienced a right-sided pneumothorax and a chest tube was placed.The patient experienced copd exacerbation which was treated with steroids.On (b)(6) 2020, a new chest tube was placed.Chest ct scans showed a right upper lobe partially fluid-filled bulla.The air leak resolved on (b)(6) 2020 and the patient was discharged on (b)(6) 2020.A follow-up appointment on (b)(6) 2020 revealed that two valves in the right upper lobe were loose.On (b)(6) 2020, the two loose valves were reimplanted.The patient was observed overnight and discharged on (b)(6) 2020.Per the physician, patient was evaluated on (b)(6) 2021 and was doing well with rv improved, unchanged fev1, 6mwd improved, and qol improvement compared to baseline.
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Search Alerts/Recalls
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