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 2018-11-21 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 5.5 EBV EBV-TS-5.5 manufactured by Pulmonx Corporation.
[128194904]
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 (b)(6) 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 (b)(6) clinical study and is an expected side effect to the zephyr valve treatment. The correct product code is njk. This product code was not accepted by the esubmitter software, most likely because it is a relatively new product code. As a result, pulmonx selected the product code oaz since the mdr could not be submitted with the correct code and the field could not be left blank. Once the product code issue is resolved, pulmonx will resubmit with the correct product code.
Patient Sequence No: 1, Text Type: N, H10
[128194905]
Patient with very severe copd underwent a bronchoscopic lung volume reduction (blvr) procedure on (b)(6) 2018, with placement of 4 zephyr valves in the left lower lobe. Post-procedure on (b)(6) 2018, the patient had an acute pneumothorax on the left side that required insertion of a chest tube. The chest tube was inserted without complications and the patient tolerated the chest tube insertion well. Subsequently the pneumothorax resolved and the patient's status improved. The chest tube was successfully removed on (b)(6) 2018. The patient was discharged from the hospital on (b)(6) 2018. Patient returned for a follow-up visit on (b)(6) 2018, and was reported to be "doing extremely well" per the physician, and the valves were confirmed to be in position. There was no pneumothorax or other complications. Patient reported that she was able to walk her dog which she had not done in 8-9 months. Patient will have post-treatment 45-day hrct for follow-up exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2018-00002 |
| MDR Report Key | 8097195 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-21 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-01-03 |
| Date Added to Maude | 2018-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LELAND KEYT |
| Manufacturer Street | 700 CHESEAPEAKE DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6502160144 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEPHYR ENDOBRONCHIAL VALVE (EBV) |
| Generic Name | ENDOBRONCHIAL VALVE |
| Product Code | OAZ |
| Date Received | 2018-11-21 |
| Model Number | ZEPHYR 5.5 EBV |
| Catalog Number | EBV-TS-5.5 |
| Lot Number | 503883-V7.0 |
| Device Expiration Date | 2020-01-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULMONX CORPORATION |
| Manufacturer Address | 700 CHESAPEAKE DRIVE REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-21 |