Safety
death, illness or injury, birth defect, illness or injury or permanent impairment, congenital abnormality
FETAL DISTRESS, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, FETAL DEATH
In this study, adverse events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patient, users, or other persons, whether or not related to the investigational medical device. Serious adverse events (SAEs) were defined as any AE that (a) led to death; (b) led to serious deterioration in the health of the patient that either resulted in (1) a life-threatening illness or injury, or (2) a permanent impairment of a body structure or a body function, or (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function; (c) led to fetal distress, fetal death or a congenital abnormality or birth defect. At each evaluation of the patient enrolled in the clinical investigation, the investigator determined whether any AE or SAE occurred and determined its possible relationship to the study devices or procedure. Adverse events were coded and summarized by MedDRA system organ class (SOC) and preferred term (PT). Causal relationships of AEs to the device were rated as unrelated, unlikely, possible, probable, or related. Adverse events were collected regardless of the relationship to the procedure or the device.