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 2018-12-05 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 4.0 EBV EBV-TS-4.0 manufactured by Pulmonx Corporation.
[129388978]
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 "njk" could not be entered into the field using esubmitter as the system called it an "invalid" code since it is a relatively new code. In order to be able to submit the mdr on time (within 30 days), the product code "oaz" was used. Pulmonx has been told by fda contact (b)(6) that the new product code njk will be available starting on dec. 3, 2018; however, it is not yet available.
Patient Sequence No: 1, Text Type: N, H10
[129388979]
On (b)(6) 2018 the patient underwent chartis assessment and bronchoscopic lung volume reduction (blvr) with zephyr valve placement in the left upper lobe. The chartis assessment was performed on the left upper lobe showing no collateral ventilation. A secondary chartis assessment was performed on the left lower lobe to confirm absence of collateral ventilation. Three valves were placed: two 4. 0 ebvs and one 5. 5 ebv. One hour after the procedure was completed, the patient presented with signs of a small pneumothorax. The patient was admitted to the icu for monitoring. On the morning of (b)(6) 2018, the pneumothorax was shown by chest x-ray to be larger and the patient was given a chest tube. The patient remained stable throughout his hospital stay and the chest tube was removed on (b)(6) 2018. The patient was discharged on (b)(6) 2018. The physician continues to follow up with the patient, and the patient is feeling well and stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2018-00008 |
| MDR Report Key | 8135057 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-05 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-08-02 |
| Date Added to Maude | 2018-12-05 |
| 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 | 2018-12-05 |
| Model Number | ZEPHYR 4.0 EBV |
| Catalog Number | EBV-TS-4.0 |
| Lot Number | 504065-V7.0 |
| 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 | 2018-12-05 |