For Patients - United States

TAVR

Transcatheter Aortic Valve Replacement

Important Safety Information
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What are the Warnings and Precautions?

Warnings

Some patients may have a disease that results in more calcium in their blood. This may cause early wear.

The Medtronic TAVR heart valve is only for certain patients. This includes patients with severe AS or failing surgical valves that:

  • Cannot have surgery.
  • Are at high risk for surgery.
 

Precautions

At some point the Medtronic TAVR heart valve may need to be replaced. How long it lasts varies from patient to patient. It has been tested to mimic 5 years of use without failure. Keep appointments with your doctor. Follow all care instructions to ensure the best possible results.

  • Antibiotics are recommended for patients who are at risk of infections.
  • Patients should stay on blood-thinning medicines after the procedure as instructed. 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 heart valve. Tell your doctor if you have a Medtronic TAVR heart valve inside a surgical valve. Not doing so could cause injury or death. Your dentist and all doctors need to know about your Medtronic TAVR heart valve. 

The Medtronic TAVR heart valve has not been studied in patients:

  • Who are not sick from AS.
  • Who are children.
  • With an aortic valve that has only one or two leaflets.
  • Who have a blood clot.
  • With an abnormal growth in the heart or arteries.
  • Who have an infection.
  • Who have AS in their own valve and a condition that allows blood to leak backwards through the aortic valve.
  • Who have severe mitral valve disease.
  • With poor left ventricle function.
  • Whose diseased 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 severe problems with bleeding or blood clotting.
  • Who have severe kidney disease that requires dialysis.
  • 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 blocks the heart from pumping blood.

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

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.