Humanitarian Device. Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (≥ 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated.
At ten months old, Matt needed open-heart surgery to treat his failing pulmonic valve. Then, just before his twelfth birthday, he started to show signs that his valve was failing again. To delay the next surgical intervention, Matt's family learned of the Melody TPV Therapy as a potential option to lengthen the time between necessary surgeries. Watch Matt McKay and his father tell their story.
At age 13, Miller was unable to walk a flight of stairs without resting, much less play actively with family and friends. His pulmonary valve conduit was failing and a replacement valve was needed. Hoping to avoid open-heart surgery as long as possible, Miller's mom searched and discovered hope in Melody TPV Therapy. Read More >
Dan is an active husband and father who enjoys snowboarding, martial arts and volleyball. Born with a heart condition called Tetralogy of Fallot, Dan had six open-heart surgeries by the time he was 19. After a near-death experience during the last surgery, Dan was determined to find a less invasive option to replace his failing pulmonary valve. Read More >
When routine tests revealed six-year-old Zoe's pulmonary valve conduit was failing, her parents scoured the Internet for an alternative to open-heart surgery. As Zoe's condition deteriorated, she became listless and had lost her energy and enthusiasm. At age six, Zoe received Melody TPV Therapy, which delayed the need for her fourth open-heart surgery. Read More >
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 complete list of possible adverse events, see Important Safety Information.
In some patients, the stent (wire frame) of the Melody TPV will 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.
For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.
This story reflects one person's experience. Not every person will receive the same results. Talk to your doctor about your treatment options.
