As with any medical procedure, there is a risk of side effects or complications during or after the Melody™ TPV procedure, which may be serious, including death. Complications that may occur during or after this procedure include:
|Melody TPV Therapy Benefits|
|Restored pulmonary valve conduit function1
||Increased pulmonary valve conduit lifespan1
|1Melody Transcatheter Pulmonary Valve Clinical Report. Data on file. Medtronic, Inc. August 2014.|
In some patients, the wire frame (stent) of the Melody TPV may fracture because of the forces it is exposed to in your body. In some cases, the fractured stent may not require additional treatment.
However, you should realize a fractured stent has the potential to become serious and could result in the need for another procedure to replace your conduit. Your doctor will decide your best treatment option. There is up to a 3% chance that your Melody TPV stent will break within one year of placement, requiring you to have another procedure.
For the complete data set, additional information and Instructions for Use documentation, contact Medtronic LifeLine CardioVascular Technical Support at 877-526-7890.
The safety and effectiveness of the Melody Transcatheter Pulmonary Valve (TPV) has only been established in patients who have a narrowed or leaky pulmonary conduit or failed bioprosthetic valve.
The safety and effectiveness of the Melody Transcatheter Pulmonary Valve has not been proven in the following: