Adverse events during 30-day post-procedure period as adjudicated by the Clinical Events Committee (CEC)
| CEC-adjudicated events | Results, n (%) (N=50) |
|---|---|
| Serious | |
| Diplopia | 1 (2.0%) |
| Headache | 1 (2.0%) |
| Retroperitoneal hemorrhage | 1 (2.0%) |
| Non-serious | |
| Access site hematoma | 1 (2.0%) |
| Carotid artery dissection | 1 (2.0%) |
| Cerebral infarction | 1 (2.0%) |
| Nausea | 2 (4.0%) |