An Unanticipated Adverse Event (UAE) will be considered any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, the commercial agent and/or surgical procedure, if that effect, problem, or death is not identified in nature, severity, or degree of incidence in this investigational plan or any other unanticipated serious problem associated with the commercial agent and/or operation that relates to the rights, safety, or welfare of the subjects participating in this study.