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 2020-03-06 for ZEPHYR ENDOBRONCHIAL VALVE (EBV) ZEPHYR 4.0-LP EBV EBV-TS-4.0-LP manufactured by Pulmonx Corporation.
[184439584]
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. Respiratory failure 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), 1. 6% of the zephyr valve subjects experienced respiratory failure during the treatment period ([less than or equal to 45 days). 0. 8% of the zephyr valve subjects and 3. 2% of the control subjects experienced respiratory failure during the longer-term period from 45 days after the study procedure through 12 months post-procedure. The zephyr ebv system ifu and pulmonx training program both specifically reference respiratory failure as a known side effect of this procedure. 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. Arrhythmias are 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), 3. 9% of the zephyr valve subjects experienced an arrhythmia event during the treatment period ([less than or equal to 45 days). 1. 6% of the zephyr valve subjects and 3. 2% of the control subjects experienced an arrhythmia event during the longer-term period from 45 days after the study procedure through 12 months post-procedure. The zephyr ebv system ifu and pulmonx training program both specifically reference arrhythmias as a known side effect of this procedure. Additionally, in the liberate study, atrial fibrillation occured in 0. 8% of the zephyr valve subjects during the treatment period and 0. 8% of the zephy valve subjects during the longer-term period from 45 days after the study procedure through 12 months post-procedure. 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. While pulmonary edema was not observed in the treated arm for liberate (the ide clinical study used to support pma p180002's approval) it was observed in the control arm in impact (valipour et al. Endobronchial valve therapy in patients with homogeneous emphysema. Results from the impact study. Am j respir crit care med, 2016;194(9), 1073-1082) at a rate of 2%. The reported event aligns with the experience observed in the impact clinical study (a supplementary study used to support pma 180002) and is a potential event that occurs in the zephyr valve patient population. 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
[184439585]
The patient is a (b)(6) female who underwent bronchoscopic lung volume reduction on 01/31/2020 with implantation of zephyr valves. The procedure was performed under general anesthesia and was uncomplicated. A post-procedure x-ray showed a large left sided pneumothorax. A chest tube was placed with near complete resolution of the pneumothorax. She had no hypoxemia or hemodynamic instability, but had chest pain on the side with chest tube. On (b)(6) 2020 the patient experienced hypercapnia respiratory failure; she was placed on non-invasive positive pressure ventilation, started on antibiotics and steroids, and was transferred to the icu for further management there was a possible left lung re-expansion edema or hemorrhage visible on the x-ray. On (b)(6) 2020 the patient was weaned off the non-invasive positive pressure ventilation with continuation of chest tube on suction. The patient experienced atrial fibrillation with rapid ventricular response. On (b)(6) 2020 the patient was put on high flow nasal cannula (hfnc; 50%) at 20l/min and packed red blood cell transfusion that was down trended with improvement of complete blood count (cbc). The hfnc was continued on 02/06/2020 at 65% and 20l/mi. The chest tube was removed on (b)(6) 2020, and the patient was discharged. Ten days later, on (b)(6) 2020 the patient was readmitted for a left lower lobe hydropneumothorax and a chest tube was inserted. Chest x-ray on (b)(6) 2020 showed consolidation (possible pneumonia). Chest tube was removed and the patient was discharged on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2020-00060 |
| MDR Report Key | 9801339 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Model Number | ZEPHYR 4.0-LP EBV |
| Catalog Number | EBV-TS-4.0-LP |
| Lot Number | 504402-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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-06 |