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1 Device-Related SAE: Adverse Event related to study device
2 Procedure-Related SAE: Adverse Event that occured during index procedure
3 Serious Adverse Events (SAE): If an event results in the following, it is automatically an SAE
• Led to a death; or
• Led to serious deterioration in the health of the subject, that either resulted in:
• A life-threatening illness or injury;
• A permanent impairment of a body structure or a body function;
• In-patient or prolonged existing hospitalization;
• Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
• Led to fetal distress, fetal death or a congenital abnormality or birth defect

4 BD data on file