Matt's Story
This story recounts the experience of one patient who received a Melody Transcatheter Pulmonary Valve. Medtronic, Inc. invited this person to share his story candidly. Caution: results vary; and patient experience may not be comparable to that of Matt's, depending in part upon the condition of the patient prior to conduit failure.
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 twelth 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.
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 complete list of possible adverse events, see Important Safety Information.
Important Information About Stent Fracture
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.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
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