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 2018-11-28 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 4.0-LP EBV EBV-TS-4.0-LP manufactured by Pulmonx Corporation.
[128863333]
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. There was one valve explanted, and two valves remain implanted. It is unknown which valve (the 4. 0 ebv or the 4. 0-lp ebv) was explanted. 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 nathan ivey that the new product code njk will be available starting on (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[128863334]
On (b)(6), 2018, the patient underwent a bronchoscopy procedure and assessment with the chartis system to determine collateral ventilation (cv) status. The patient was eligible for bronchoscopic lung volume reduction (blvr) with zephyr valves in right upper lobe (rul) on ct. Three valves were placed in the rul. Immediately following the procedure in the pacu, the patient developed respiratory distress unresponsive to iv steroids and duonebs therefore a stat chest x-ray was ordered revealing a right apical pneumothorax, without tension. A small-bore chest tube was placed into right apex and connected to water seal. Daily chest x-rays were repeated with improvement in the pneumothorax. On (b)(6) 2018, the patient was discharged home with a heimlich valve and no detectable air leak. She was seen in clinic for follow-up on 8 days post-procedure and 15 days-post procedure ((b)(6) 2018) with heimlich valve in place. Both times she was unable to tolerate clamping of her heimlich valve. Chest x-rays revealing persistent right apical pneumothorax, decreased in size from prior. On (b)(6) 2018, the decision was made to remove one (1) valve in the anterior segment to improve dyspnea. She is doing well in stable condition, and continues to be monitored in the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2018-00004 |
| MDR Report Key | 8113723 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-28 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-08-25 |
| Date Added to Maude | 2018-11-28 |
| 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 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6502160144 |
| Manufacturer G1 | PULMONX CORPORATION |
| Manufacturer Street | 700 CHESAPEAKE DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94063 |
| 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 | 2018-11-28 |
| Model Number | ZEPHYR 4.0-LP EBV |
| Catalog Number | EBV-TS-4.0-LP |
| Lot Number | 504084-V7.1 |
| 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 | 2018-11-28 |