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.
[186510856]
Decreased oxygen saturation is an anticipated, potential 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). In the liberate study (ide clinical study used to support pma p180002's approval), 0. 8% of the zephyr valve subjects experienced decreased oxygen saturation during the treatment period ([less than or equal to 45 days). The reported event aligns with the experience observed in the liberate clinical study and is an anticipated, potential side effect to the zephyr valve treatment. The reported event was foreseeable and clinically acceptable in view of the expected patient benefit from the treatment.
Patient Sequence No: 1, Text Type: N, H10
[186510857]
On (b)(6) 2020 the patient had zephyr valves implanted. The patient required maximum oxygen in recovery and o2 saturation was 86. After a few hours of observation, the o2 saturation remained low. The decision was made to explant all zephyr valves. Once the valves were removed, the o2 saturation was 97 on maximum oxygen. The patient was admitted overnight for observation and discharged on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2020-00075 |
| MDR Report Key | 9880153 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-12-04 |
| 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 | 504656-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 |