Model Number ZEPHYR 4.0 EBV |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Date 09/08/2019 |
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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Patient was treated on (b)(6) 2019 with three zephyr valves placed in the right upper lobe (rul), (4.0 ebv - rb1, 4.0 ebv - rb2, 5.5 ebv - rb3).The patient was discharged on (b)(6) 2019.On (b)(6) 2019, the patient had signs of a pneumothorax and went to the emergency room at another facility and a chest tube was inserted.On (b)(6) 2019, the patient was transferred to the treating hospital and admitted.On (b)(6) 2019, the patient underwent a bronchoscopy to treat the airleak and three olympus valves were placed for resolution of the airleak.On (b)(6) 2019, the patient underwent a bronchoscopy to remove one olympus valve and one zephyr 4.0 valve from rb2.On (b)(6) 2019, the chest tube was removed and the patient was discharged with no further complications.
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Manufacturer Narrative
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Event has been updated with corrected data.No other corrections have been made.
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Event Description
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Patient was treated on (b)(6) 2019 with three zephyr valves placed in the right upper lobe (rul), (4.0 ebv - rb1, 4.0 ebv - rb2, 5.5 ebv - rb3).The patient was discharged on (b)(6) 2019.On (b)(6) 2019, the patient had signs of a pneumothorax and went to the emergency room at another facility and a chest tube was inserted.On (b)(6) 2019, the patient was transferred to the treating hospital and admitted.On (b)(6) 2019, the patient underwent a bronchoscopy to treat the air leak.On (b)(6) 2019, the patient underwent a bronchoscopy to remove valves.On (b)(6) 2019, the chest tube was removed and the patient was discharged with no further complications.The clinical investigation is on-going.Details on the treatment of the air leak and which valves were removed will be provided in a follow-up report.
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Event Description
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Patient was treated on (b)(6) 2019 with three zephyr valves placed in the right upper lobe (rul), (4.0 ebv - rb1, 4.0 ebv - rb2, 5.5 ebv - rb3).The patient was discharged on (b)(6) 2019.On (b)(6) 2019, the patient had signs of a pneumothorax and went to the emergency room at another facility and a chest tube was inserted.On (b)(6) 2019, the patient was transferred to the treating hospital and admitted.On (b)(6) 2019, the patient underwent a bronchoscopy to treat the air leak and 3 olympus valves were placed.On (b)(6) 2019, the patient underwent a bronchoscopy to remove one 4.0 zephyr valve and one olympus valve from the rb2.The physician decided to remove the least number of valves adequate to expand the lung and resolve the pneumothorax under fluoroscopy and clinically.On (b)(6) 2019, the chest tube was removed and the patient was discharged with no further complications.
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Manufacturer Narrative
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Section b5 has been updated with additional details after receiving information from the treating physician.No other edits have been made.
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Search Alerts/Recalls
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