Complications and adverse events per procedure
| Periprocedural (In-Hospital Stay) (No.) | During Follow-Up (after Hospital Discharge) (No.) | |
|---|---|---|
| Complications | ||
| Spontaneous rupture of the FRED-treated aneurysm | 0 | 2 |
| Spontaneous nonaneurysmal intracranial hemorrhage | 3 | 1 |
| Symptomatic ischemic stroke | ||
| Minor (≤1 mo) | 8 | 5 |
| Major (>1 mo) | 2 | 1 |
| Stent/parent artery stenosis | 5 | 3 |
| Stent/parent artery occlusion | 4 | 8 |
| Permanent cranial neuropathy | 0 | 0 |
| Other complications | ||
| Groin hematoma | 1 | |
| Dissection | 1 | |
| Aneurysm growth | 2 | |
| Total | 24 (4.5%) | 22 (4.1%) |
| Adverse events | ||
| Detachment in the hub of the microcatheter | 2 | |
| Poor opening on deployment | 10 | |
| Torquing of stent on deployment | 1 | |
| Multiple repositioning | 2 | |
| Visible gap between inner and outer stent | 1 | |
| Fish mouthing of the distal stent end | 13 | |
| Total | 15 (2.8%) | 14 (2.6%) |
| Transient morbidity (≤90 days) | 10 (1.9%) | 7 (1.3%) |
| Permanent morbidity (>90 days) | 3 (0.6%) | 1 (0.2%) |
| Mortality | 4 (0.75%) | 4 (0.75%) |