Results in death; Is life-threatening, i.e., an event that places the subject, in the view of the Investigator, at immediate risk of death from the event as it occurred (does not include an event that, had it occurred in a more severe form, might have caused death); Requires inpatient hospitalization or prolongation of an existing hospitalization; Results in persistent or significant disability or incapacity; Results in cancer; Results in a congenital anomaly or birth defect; Other medically important events that in the opinion of the Investigator may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above; Any serious problem associated with the device that relates to the rights, safety or welfare of study subjects.