Periprocedural complications
| Aneurysm | |||
| Ruptured | Un-ruptured | Overall | |
| Access site complications, % (n/N) | |||
| Total | 0.4% (1/264) | 4.1% (24/587) | 2.9% (25/851) |
| Event status* | |||
| Not serious | 0.4% (1/264) | 3.7% (22/587) | 2.7% (23/851) |
| Serious | 0.0% (0/264) | 0.3% (2/587) | 0.2% (2/851) |
| Relationship† | |||
| Procedure-related | 0.4% (1/264) | 4.1% (24/587) | 2.9% (25/851) |
| Device-related | 0.0% (0/264) | 0.0% (0/587) | 0.0% (0/851) |
| Aneurysm re-rupture/rupture or perforation, % (n/N) | |||
| Total | 3.4% (9/264) | 2.7% (16/587) | 2.9% (25/851) |
| Event status* | |||
| Not serious | 1.5% (4/264) | 0.7% (4/587) | 0.9% (8/851) |
| Serious | 1.9% (5/264) | 2.0% (12/587) | 2.0% (17/851) |
| Relationship† | |||
| Procedure-related | 2.7% (7/264) | 2.6% (15/587) | 2.6% (22/851) |
| Device-related | 2.3% (6/264)) | 1.9% (11/587) | 2.0% (17/851) |
| Dissection, % (n/N) | |||
| Total | 0.0% (0/264) | 0.7% (4/587) | 0.5% (4/851) |
| Event status* | |||
| Not serious | 0.0% (0/264) | 0.2% (1/587) | 0.1% (1/851) |
| Serious | 0.0% (0/264) | 0.5% (3/587) | 0.4% (3/851) |
| Relationship† | |||
| Procedure-related | 0.0% (0/264) | 0.7% (4/587) | 0.5% (4/851) |
| Device-related | 0.0% (0/264) | 0.0% (0/587) | 0.0% (0/851) |
| Thromboembolic events, % (n/N) | |||
| Total | 8.3% (22/264) | 3.6% (21/587) | 5.1% (43/851) |
| Event status* | |||
| Not serious | 3.0% (8/264) | 1.5% (9/587) | 2.0% (17/851) |
| Serious | 5.3% (14/264) | 2.0% (12/587) | 3.1% (26/851) |
| Relationship† | |||
| Procedure-related | 7.2% (19/264) | 3.2% (19/587) | 4.5% (38/851) |
| Device-related | 4.2% (11/264) | 2.7% (16/587) | 3.2% (27/851) |
*An event is reported as serious if it led to death or led to a serious deterioration in the health of the patient that resulted in life-threatening illness or injury, resulted in permanent impairment of a body structure or body function, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in medical or surgical intervention to arrest permanent impairment to body structure or body function.
†An event can be reported as both procedure- and device-related. Any relationship (possible, probable, or definite) besides unrelated was considered as related.