Potential risks (listed from most to least severe) associated with the implantation of the study valve may include, but are not limited to, the following:

• Death
• Acute myocardial infarction - heart attack; decrease blood flow to the heart causing death of an area of the heart muscle
• Stroke - decreased blood flow to the brain causing death of the brain cells
• Urgent need for surgery
  • Coronary artery bypass – a surgery where the chest is opened to place new vessels around the existing blocked vessels of the heart to improve blood supply to the heart.
  • Heart valve replacement – replacing the existing heart valve with a new heart valve
  • Valve explant – the removal of the existing valve
• Urgent need for balloon valvuloplasty (balloon valvuloplasty during the TAVI procedure is expected) – a procedure through the vessels inside the body and heart in which a narrowed heart valve is stretched open
• Urgent need for Percutaneous Coronary Intervention (PCI) – a procedure through the vessels inside the body and heart used to treat or open narrowed vessels of the heart
• 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 build up 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
• Myocardial ischemia – reduced blood supply to the heart
• Acute coronary artery occlusion – blockage or closure of an artery that supplies the heart with blood
• Disturbances in the electrical system of the heart that may result in the permanent placement of a device (pacemaker) that delivers electrical impulses to the heart to help your heart beat normally.
  • Atrio-ventricular node block – a block in the electrical path from the top part of the heart (atria) to the bottom part of the heart (ventricle)
  • Bundle branch block – a delay or block in the electrical path in the bottom part of the heart (ventricle)
  • Asystole – when the heart stops beating
• Ventricular arrhythmias – abnormal fast or slow heart beats in the lower part of the heart (ventricles)
• Valve or distal 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
• Hemorrhage requiring transfusion – bleeding requiring blood to be put back into the body
• Arteriovenous fistula – abnormal connection between an artery vessel that takes blood away from the heart and a vein vessel that takes blood to the heart
• Vessel dissection or spasm – the separation of the walls of a vessel or a sudden narrowing of the vessel)
• Valve migration – upward or downward movement of the device from where it was originally placed
• Valve dysfunctions of the CoreValve including but not limited to:
  • Fracture (break) in the valve frame
  • Bending (out-of-round configuration) of the valve frame
  • The valve frame does not open (expand) all the way
  • Calcification (build up 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
  • The 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 or placement 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 – a leaking valve between the left upper (left atrium) and left lower (left ventricle) parts of the heart where blood flows backward through the valve
• Hypotension or hypertension - low or high blood pressure
• Acute renal injury - failure of the kidneys to work correctly
• Allergic reaction (unfavorable reaction by the body) to
  • antiplatelet agents - drugs that keep blood clots from forming
  • contrast medium - a substance used to increase the visualization of body structures such as x-ray dye
• Infection including infection of the heart or heart valves (endocarditis) – an abnormal growth of germs in the body or body part
• Bowel ischemia –decrease blood supply to the intestines
• Complications at the area where the doctor opened the skin or related to opening 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 vessel (artery)