Melody PB1016 Surveillance Study

Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Inclusion Criteria:

• Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Exclusion Criteria:

• Implantation in the aortic, tricuspid, or mitral position
• Venous anatomy unable to accommodate a 22-Fr size introducer sheath
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• History of intravenous substance abuse
• Currently participating in an investigational drug or device study