Ms. Reynolds was admitted to the hospital with a heart attack. She undergoes an emergent cardiac catheterization, and the cardiologist determines that she needs a cardiac stent placed immediately. However, the artery requiring the stent is very small and tortuous, and the only available suitable stent is labeled “investigational.” The cardiologist decides that Ms. Reynolds is in a life-threatening situation due to her evolving myocardial infarction and use of the investigational stent offers Ms. Reynolds the best chance for surviving the event without further damage to her heart