Table 3

Level of relatedness for all strokes – as adjudicated by CEC

Level of relatednessRelatedness to deviceRelatedness to procedure
Minor stroke
 Definitely1.3% (2/153)2.6% (4/153)
 Probably0.7% (1/153)0.7% (1/153)
 Possibly2.0% (3/153)0.7% (1/153)
 Unlikely0.0% (0/153)0.0% (0/153)
 Unrelated0.0% (0/153)0.0% (0/153)
Major stroke
 Definitely0.7% (1/153)2.6% (4/153)
 Probably1.3% (2/153)0.0% (0/153)
 Possibly0.7% (1/153)0.7% (1/153)
 Unlikely0.0% (0/153)0.7% (1/153)
 Unrelated3.9% (6/153)2.6% (4/153)