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Transcatheter Aortic Valve Replacement

Important Safety Information
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Understanding the Medtronic TAVR Procedure

Patient Animation Video

simpl-pdf-icon Download the Medtronic TAVR Patient Brochure


A Typical Medtronic TAVR Procedure


  1. Because each patient is different, your doctor will determine if you should be fully asleep during the 1-2 hour procedure.
  2. The doctor will make a cut and guide a long tube (sheath) into your artery.
  3. A thin, flexible tube (catheter) with a balloon on the tip may be placed into your heart. When the end of the balloon gets to your aortic valve, the balloon will be inflated. This will force your diseased aortic valve open and prepare it for the CoreValve heart valve.
  4. Your doctor will place the CoreValve heart valve in position over your own diseased heart valve or your failing surgical valve. (Figures 1 and 2)
  5. Your new CoreValve heart valve will begin opening and closing. The doctor will conduct a test to confirm it is working properly. (Figure 3)
  6. The thin, flexible tube will be removed, the cut will be closed, and the operation will be complete.

Machines that use sound waves or X-rays to look at your heart and arteries will be used during the procedure.

Note: Step 3 may not apply to you if you have a failing surgical valve based on your valve condition.

CoreValve Procedure Image



Most medical procedures have risks. The CoreValve procedure's most serious risks are:

  • Death.
  • Stroke.
  • Serious damage to the arteries.
  • Serious bleeding.

For a full list of potential risks at 30 days and 1 year post implant, please download the Medtronic TAVR Patient Brochure.


Other Potential Risks Associated with the Medtronic TAVR Heart Valve


  • Cardiogenic shock - failure of the heart to pump enough blood to the body organs.
  • Perforation of the myocardium or vessel - a hole in the heart muscle or a blood vessel.
  • Cardiac Tamponade - the constriction or inability of the heart to pump due to buildup of blood or fluid around the lining of the heart.
  • Ascending aorta trauma - injury to the large blood vessel leading blood away from the heart.
  • Embolism - an abnormal particle (air, blood clots) floating in the blood stream or attached to an object, including the valve.
  • Thrombosis (including valve thrombosis) - blood clot, including a blood clot on the valve.
  • Valve migration - upward or downward movement of the device from where it was originally placed.
  • Valve dysfunctions of the CoreValve device 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.
  • Mitral valve regurgitation - blood leaking backwards 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.
  • 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.
  • Bowel ischemia - decreased blood supply to the intestines.
  • 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).

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


The Medtronic TAVR Heart Valve Should NOT be Used for the Following People

Patients who:

  • Have an infection.
  • Have a mechanical valve.
  • Cannot take blood thinning medicines.
  • Have a reaction to some metals.
  • Have a reaction to some imaging solutions.

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