The purpose of this study is to evaluate the functionality of transcatheter implantation (a minimally invasive procedure) of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV). Significant pulmonary regurgitation (abnormal reversal of blood flow in the heart) often occurs in people who have previously treated congenital heart disease with a missing or malformed pulmonary valve and do not have a tube connecting the right pumping chamber (ventricle) and the lung artery (pulmonary artery). These patients require an operation to treat the pulmonary valve and improve the regurgitation caused by the condition. The Medtronic Harmony Transcatheter Pulmonary Valve is different than having open heart surgery because a small needle puncture is made into the groin or neck, instead of cutting the chest open. The doctor will then insert the new heart valve through a long, flexible tube (catheter) and guide it to the heart through a vein and place it into the area between the heart and lungs. The Harmony TPV system is approved by the U.S. Food and Drug Administration (FDA) for patients who have severe pulmonary regurgitation and have a native or surgically repaired right ventricular outflow tract (RVOT).