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 2020-03-03 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 4.0 EBV EBV-TS-4.0 manufactured by Pulmonx Corporation.
[181920610]
A detailed physician's narrative is still pending and expected to be provided soon. The internal clinical investigation has not yet been completed. A follow-up report with more information will be submitted after receipt of the physician's narrative. 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
[181920611]
On (b)(6) 2020, the patient underwent a bronchoscopy lung volume reduction (blvr) procedure with 5 zephyr valves (4. 0-lp ebv and 4. 0 ebv) placed in the right upper lobe (rul) and right middle lobe (rml). On (b)(6) 2020, the patient became short of breath, a chest x-ray confirmed the presence of a pneumothorax, and an 18 french chest tube was placed. On (b)(6) 2020, the patient developed an air leak and subcutaneous emphysema. The subcutaneous emphysema was successfully treated via surgical release, and the 18 french chest tube was replaced with a 14 french chest tube. The patient was on up to 8l of oxygen, which was subsequently reduced back to his baseline of 4-5l oxygen. Patient had all valves except one 4. 0 ebv removed (date not known), and his symptoms appeared to be improving (subcutaneous emphysema, air leak, pneumothorax) when the physician checked on him the next day, though he had developed renal failure requiring dialysis. Later that evening, however, the patient developed rapid atrial fibrillation which was managed with medications following cardiac consult, leading to hypotension, acidosis, and ultimately shock and multi-organ failure. All attempts were made to address this change in status with little success. Following a conversation with the patient's family, the decision was made to place the patient under comfort care. The patient passed away shortly following extubation. The treating physician stated that the cause of death was shock and multi-organ failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2020-00053 |
| MDR Report Key | 9783095 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-11-01 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| 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 | 2020-03-03 |
| 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. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-03 |