ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 5.5 EBV EBV-TS-5.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 5.5 EBV EBV-TS-5.5 manufactured by Pulmonx Corporation.

Event Text Entries

[186551826] 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.
Patient Sequence No: 1, Text Type: N, H10


[186551827] The patient had a bronchoscopic lung volume reduction (blvr) procedure with four zephyr valves (two 4. 0 ebvs, two 5. 5 ebvs) placed in the left upper lobe (lul) on (b)(6) 2020. Patient was discharged on (b)(6) 2020, and returned to the hospital on (b)(6) 2020 with a large pneumothorax. A chest tube was placed on (b)(6)2020. On (b)(6) 2020, the patient had a surgery for a bullae rupture/air leak. The air leak resolved, and the patient had complete lul atelectasis. The patient was discharged on (b)(6) 2020 with a chest tube in place. There was no air leak at the time of discharge. The physician is planning to remove the chest tube on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007797756-2020-00081
MDR Report Key9908947
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-29
Date Mfgr Received2020-03-01
Device Manufacturer Date2019-10-23
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LELAND KEYT
Manufacturer Street700 CHESAPEAKE DRIVE
Manufacturer CityREDWOOD CITY, CA
Manufacturer CountryUS
Manufacturer Phone2160144
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZEPHYR ENDOBRONCHIAL VALVE (EBV)
Generic NameENDOBRONCHIAL VALVE
Product CodeNJK
Date Received2020-03-31
Model NumberZEPHYR 5.5 EBV
Catalog NumberEBV-TS-5.5
Lot Number504600-V7.0
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPULMONX CORPORATION
Manufacturer Address700 CHESAPEAKE DRIVE REDWOOD CITY, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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