When Sadie Rutenberg was born, she had a gaping hole between the two sides of her heart, and her heart valves were malformed and leaking.

In her first few months of life, she had already undergone two open-heart surgeries; but the damage was too extensive to repair, and the blond-haired, blue-eyed infant was failing to thrive. Her parents said there was no choice — they would have to take a risk, or their child might not survive.

So, the Seattle couple made what they said was the only logical decision: Their 6-month-old daughter would receive the world's tiniest mechanical heart valve.

At the time, in 2015, Abbott's Masters HP 15-mm rotatable mechanical heart valve had not yet been fully approved by the U.S. Food and Drug Administration. Sadie would become the first child in the United States to try it.