INSPIRIS RESILIA aortic valve
Indications: For use in replacement of native or prosthetic aortic heart valves.
Contraindications (Who should not receive): There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.
Complications and Side Effects: The risks with the INSPIRIS RESILIA aortic 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
- 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.
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.
KONECT RESILIA aortic valved conduit
Indications: For use in replacement of native or prosthetic aortic heart valves and the associated repair and replacement of a damaged or diseased ascending aorta.
Contraindications (Who should not receive): There are no known contraindications with the use of the KONECT RESILIA aortic valve conduit.
Complications and Side Effects: The risks with the KONECT RESILIA aortic valve conduit 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
- Allergic reaction to the materials in the valve or graft
- Graft infection
- Ballooning and weakening of an area in an artery
- Blood collecting between the layers of an artery
- Fluid buildup under the surface of the skin
- Fluid buildup around the graft
- Blockage of a blood vessel
- New tissue growth on the graft
- Enlargement of the graft
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 these devices to sale by or on the order of a physician.