Primary endpoint analysis
| Variable | Overall | One sided upper 96% exact binomial CI (%) | Threshold |
| By patient | 0/112 (0.0%) | 2.8 | 9.6% |
| Premature (unintentional) catheter tip detachment with clinical sequelae | 0/112 (0.0%) | N/A | N/A |
| Catheter rupture/break/fracture with clinical sequelae | 0/112 (0.0%) | N/A | N/A |
| Retained catheter body in the vasculature | 0/112 (0.0%) | N/A | N/A |
| By device* | 0/126 (0.0%) | 2.5 | 9.6% |
| Premature (unintentional) catheter tip detachment with clinical sequelae | 0/126 (0.0%) | N/A | N/A |
| Catheter rupture/break/fracture with clinical sequelae | 0/126 (0.0%) | N/A | N/A |
| Retained catheter body in the vasculature | 0/126 (0.0%) | N/A | N/A |
Data are count/sample size (%).
*Includes only study devices within the first 30 days after the initial embolization procedure.