Typically, the Melody TPV procedure takes 1-2 hours. Patients are asleep for the procedure and usually don’t feel any pain.
- The catheter is inserted into the patient’s femoral vein through a small access site.
- The catheter holding the Melody valve is placed in the vein and guided into the patient’s heart.
- Once the Melody valve is in the right position, the balloons are inflated.
- The Melody valve expands into place and blood will flow between the patient’s right ventricle and lungs.
- The catheter is removed.
- Fluoroscopy confirms that the Melody valve is functioning properly.
- The access site is closed.
Important Risk Information
Potential procedural complications that may result from implantation of the Melody device include the following: Rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, pain at the catheterization site.
Potential device-related adverse events that may occur following TPV implantation include the following: Stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.
*For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.
Important Information About Stent Fracture
In some patients, the stent (wire frame) of the Melody TPV may break because of the forces it is exposed to in the body. The chance of the stent breaking may increase the longer the device is in the body. There is up to a 35 percent chance that the Melody TPV stent will break within one year of placement.* In some cases, the broken stent does not require additional treatment. A doctor will determine the best treatment option.
However, a broken stent has the potential to become serious and could result in the need for another catheter intervention, an operation to replace the conduit, or could lead to death.
