Table 3 List of serious adverse events

a death

b serious deterioration in the health of the subject, that resulted in any of the following:

 (I) life-threatening illness or injury,

 (II) permanent impairment of a body structure or a body function,

 (III) hospitalization or prolongation of patient hospitalization,

 (IV) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,

 (V) chronic disease

c Acute limb ischemia as a result of the procedure e.g. peripheral embolization

d Necessary thrombectomy/revision as a result of the procedure (surgical or interventional)

e Unplanned major amputation, above or below the knee