IMPORTANT SAFETY INFORMATION Melody™ Transcatheter Pulmonary Valve (TPV) Therapy

POSSIBLE RISKS

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:

• Pain, swelling, and bruising at the site where the thin, hollow tube (catheter) entered your body
• Bleeding or pain at the site where the thin, hollow tube (catheter) entered your body
• Fever
• Reddening, peeling, or blistering of the skin due to x-rays
• Infection
• Irregular heart beat
• Tearing of the blood vessel where the thin, hollow tube (catheter) is inserted
• Tearing of a heart chamber or the pulmonary conduit
• Allergic reaction to the x-ray dye
• Stroke (a condition in which decreased blood flow to the brain causes brain cells to die)
• Breakage of the wire frame (stent fracture) that supports the tissue valve
• Leakage or narrowing of the valve
• Infection of the valve (endocarditis)
• Tearing of the conduit during the procedure
• Squeezing of the arteries near the failed conduit when the stent or valve is expanded
• Development of a blood clot within the valve which affects its function or travels to the lung
• Movement of the valve from where it was implanted
• Breakdown of red blood cells
• Leakage of blood around the valve or valve frame
• Poking a hole in a large vessel (perforation)

IMPORTANT INFORMATION ABOUT STENT FRACTURE

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.

ADDITIONAL WARNINGS AND PRECAUTIONS

Warnings
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.

Precautions
The safety and effectiveness of the Melody Transcatheter Pulmonary Valve has not been proven in the following:

• Patients who have a disease of their aortic valve (valve that controls blood from the heart to the body) or mitral valve (valve that controls blood from the top left chamber of the heart to the bottom left chamber of the heart). The Melody TPV may not work properly when used in these locations.
• Patients whose blood vessels are not big enough for the catheter to be used to deliver the valve.
• Patients who have an infection in the heart (endocarditis) or somewhere else in the body.