Important safety information
Transcatheter aortic valve replacement (TAVR)

Multiple clinical trials have been conducted to provide information about the chance of a risk from the Medtronic TAVR procedure. TAVR currently is approved for patients with heart disease due to symptomatic severe aortic stenosis of the native valve, and patients with a failing surgical aortic valve who are at high risk or extreme risk due to symptomatic, severe aortic stenosis for complications during surgery.

A number of factors determine a patient’s risk, including age and other medical conditions that make surgery more dangerous. Your doctor can let you know which risks will most likely apply to you.

Potential risks

• Heart attack
• Cardiogenic shock — failure of the heart to pump enough blood to the body organs
• Cardiac tamponade — the constriction or inability of the heart to pump due to buildup of blood or fluid around the lining of the heart
• Perforation of the myocardium or vessel — a hole in the heart muscle or a blood vessel
• Partial or complete block of coronary artery (that supplies blood to the heart)
• Ascending aorta trauma — injury to the large blood vessel leading blood away from the heart
• Additional cardiac surgery, vascular surgery, or intervention, including removal of the TAV
• Dysfunctions of a Medtronic TAVR valve, including but not limited to:
  • Break (fracture) in the valve frame
  • Bending of the valve frame
  • Valve frame does not open (expand) all the way
  • Buildup of calcium on the valve
  • Pannus — the formation of scar tissue that may cover or block the valve from functioning normally
  • Wear, tear, or movement forward (prolapse) or backward (retraction) from the normal position of the valve leaflets
  • Valve leaflets do not close together
  • A break in the stitches (sutures) of the valve frame or leaflets
  • Leakage through or around the valve or valve frame
  • Incorrect size of the valve implanted
  • Incorrect position of the valve, either too high or too low
  • Regurgitation — backward flow of blood through the valve
  • Stenosis — narrowing of the opening of the valve
• Valve migration — upward or downward movement of the device from where it was originally placed
• Embolism — an abnormal particle (air, blood clots) floating in the blood stream or attached to an object, including the valve or delivery system component
• Infection of the heart, blood, or other areas
• Thrombosis (including valve thrombosis) — blood clot, including a blood clot on the valve
• Prolonged procedure time
• Individual or multi-organ insufficiency or failure
• Complications at the area where the doctor cut the skin or related to cutting the skin, including but not limited to:
  • Pain
  • Bleeding
  • Hematoma — blood collecting under the skin
  • Pseudoaneurysm — blood collecting on the outside of a vessel wall causing a balloon-like widening
  • Irreversible nerve damage — permanent damage to nerves
  • Compartment syndrome — squeezing of nerves and muscles in a closed space that could cause muscle or nerve damage
  • Stenosis — narrowing of a blood vessel (artery)
  • Decreased blood flow to your leg or arm
• Mitral valve regurgitation — blood leaking backward through the valve between the left lower chamber of the heart to the left upper chamber of the heart
• Hypotension or hypertension — low or high blood pressure
• Damage to the red blood cells
• Bowel ischemia — decreased blood supply to the intestines
• Lab values that are not normal
• Unfavorable reaction by the body (allergic reaction) to:
  • Antiplatelet agents — blood-thinning medicines that keep blood clots from forming
  • Contrast medium — a substance used to increase the visualization of body structures such as X-ray dye
• Exposure to radiation
• Permanent disability

In addition, you may experience other problems that have not been previously observed with this procedure.

Warnings and precautions

Warnings: Younger patients, or patients with a disease that results in more calcium in their blood, may have early wear of their valve.

Precautions:

• At some point, the Medtronic TAVR valve may need to be replaced. How long it lasts varies from patient to patient.
  
• The Medtronic TAVR valve has been tested in the laboratory to mimic five years of typical use without failure. Keep appointments with your doctor. Follow all care instructions to ensure the best possible results.
• Antibiotics may be recommended for patients who are at risk of infections.
• Patients should stay on medications that reduce the risk of blood clots after the procedure as instructed by your physician. Patients who do not are more likely to have a stroke.
• If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. Not doing so could result in injury or death. Your dentist and all doctors need to know about your Medtronic TAVR valve.

The Medtronic TAVR valve has not been studied in patients:

• Who are children
  
• Who have a blood clot
• With an abnormal growth in the heart or arteries
• Who have an infection
• Who have severe mitral valve disease
• With poor left ventricle function
• Whose failing valve is too small or too big
• Whose arteries are too small for the device
• Whose arteries that deliver blood to the heart may be blocked by the device
• Whose arteries that deliver blood to the heart need to be treated
• Whose arteries that deliver blood to the brain need to be treated
• Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to some metals
• Who have severe problems with bleeding or blood clotting
• Who have specific types of surgical valves implanted in the pulmonary valve
• Who have specific types of surgical valves implanted in the mitral valve
• Who have thick heart muscles, making it difficult for the heart to pump blood
• Who have thick heart muscles that block the heart from pumping blood
• Who are pregnant or breastfeeding
• With liver failure
• Who need to have a surgical procedure on their aorta 

If the Medtronic TAVR valve is used in these patients, it may not work right. This could make you feel sick or cause death.

For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Please talk to your doctor to decide whether this therapy is right for you.