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 2020-03-25 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 4.0 EBV EBV-TS-4.0 manufactured by Pulmonx Corporation.
[186511060]
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
[186511062]
On (b)(6) 2020 the patient had four zephyr valves implanted. On (b)(6) 2020, the patient experienced a tension pneumothorax. The patient was admitted to the hospital and had a chest tube placed. On (b)(6) 2020, the lobe had re-expanded but there was still an air leak. As of (b)(6) 2020, the air leak is still ongoing and the chest tube is still in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2020-00071 |
| MDR Report Key | 9880162 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-11-01 |
| Date Added to Maude | 2020-03-25 |
| 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 CHESAPEAKE DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2160144 |
| 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 | NJK |
| Date Received | 2020-03-25 |
| Model Number | ZEPHYR 4.0 EBV |
| Catalog Number | EBV-TS-4.0 |
| Lot Number | 504619-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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-25 |