Important Safety Information

Heart Valve Repair Important Safety Information

St. Jude Medical heart valve repair devices are indicated for use in the repair of valves that are diseased or damaged due to acquired or congenital processes.

As with any surgery, there are also risks involved with heart valve repair surgery. Though rare, some of the potential complications include abnormal heart rhythms, narrowing of the valve opening, infection, bleeding, stroke, heart attack and death. In some cases, your heart valve may not function as needed. This is not typical but you may need another surgery to treat it.

Individual risks are best evaluated by your heart surgeon and cardiologist. Generally, risks depend on age, general health, specific medical conditions and heart function. Talk to your doctor to better understand your potential benefits and risks.

Heart Valve Replacement Important Safety Information

St. Jude Medical prosthetic heart valves are indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve.

There are risks with any heart valve replacement. These may include, but are not limited to, blood cell damage (hemolysis), low red blood cell count (hemolytic anemia), bleeding, infection, clotting in or on the valve (thrombus formation), tissue on the valve (valvular pannus), loose clots in the blood stream that may block an artery in your arms, legs or brain (thromboembolism), valve failure (which may include structural damage), leakage around the edge of the valve (paravalvular leak), need for reoperation, explantation, arrhythmia, stroke, angina, heart failure, and death.

Anticoagulation is recommended for patients with mechanical valve implants.

Individual risks are best evaluated by your heart surgeon and cardiologist. Generally, risks depend on age, general health, specific medical conditions and heart function. Talk to your doctor to better understand your potential benefits and risks.

Last Reviewed: January 19, 2010 2506