Mitral Valve Replacement Surgery

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Important Risk Information:
MITRIS RESILIA Mitral Valve

Indications: For use in replacement of native or prosthetic mitral heart valves. 

Contraindications (Who should not receive):  There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects: The risks with the MITRIS RESILIA mitral valve are similar to risks with other heart valves, and include the following:

• Heart failure
• Leaking from the valve or areas around the valve
• Improper opening and closing of the valve
• Damage to red blood cells that can result in low red blood cell count
• Heart lining inflammation
• Heart infection
• Abnormal bleeding or bleeding problems from using blood thinners
• Clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow
• Heart attack
• Heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm
• Injury could occur to the heart tissue or blood flow could be blocked
• Allergic reaction to the materials in the valve

These could lead to the need for reoperation to replace the valve, permanent disability, or death. This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor. 

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

Indications: 
For use in replacement of native or prosthetic mitral heart valves. 

Contraindications: 
(Who should not use): There are no known contraindications with the use of the MITRIS RESILIA mitral valve. 

Complications and Side Effects: 
Heart failure, leaking from the valve or areas around the valve, improper opening and closing of the valve, damage to red blood cells that can result in low red blood cell count, heart lining inflammation, heart infection, abnormal bleeding or bleeding problems from using blood thinners, clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow, heart attack, heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm, these could lead to the need for reoperation to replace the valve, permanent disability, or death. This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor. 

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 
See Instructions for Use for full 
prescribing information.