Medtronic

Melody

Caution: Investigational device. Limited by United States law to investigational use.

Important Safety Information

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)

 

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