Event | PC400 | Control |
---|---|---|
Retroperitoneal hematoma | 2 | |
Catheter instability | 1 | 1 |
Coil migration | 2 | 1 |
In-stent stenosis | 8 | |
Parent or distal vessel compromise | 3 | |
Thrombus/platelet plug formation | 9 | |
Arterial dissection | 1 | |
Cerebrovascular accident | 2 | |
Contrast extravasation/aneurysm rupture | 2 | 4 |
Intracerebral hemorrhage | 1 | |
Total number of events | 5 | 32 |
Total number (%) of patients affected | 5 (6.7%) | 27 (9.5%) |
Death or permanent disability due to adverse event | 1 (1.3%) | 6 (2.1%) |
PC400, Penumbra coil.