Important Safety Information Heart Valve Disease

Freestyle Valve

The Freestyle valve is used to replace your heart's natural valve when it has become diseased or weakened by age. It can also be used to replace your prosthetic valve when it is no longer working properly. (A prosthetic valve is a replacement valve made of human, animal, or artificial materials.)

Valve replacement can include the following risks:

  • Angina.
  • Abnormal heart beat (cardiac arrythmia and dysrhythmia).
  • Blood leaking around the outside of the prosthetic valve (paravalvular leak) or any problem with the valve that causes leaking of blood after the valve has closed (transvalvular leak).
  • Damage to red blood cells (hemolysis) that can result in anemia.
  • Death.
  • Inflammation of the lining of the heart (endocarditis).
  • Heart failure.
  • Any problem with the prosthetic valve that causes narrowing of the valve opening (stenosis).
  • Blood clots that develop in the heart or on the replacement valve. These clots may break loose and travel through the bloodstream (thromboembolism). This problem may cause a stroke or heart attack.
  • Collection of blood within the replacement valve leaflets (intracuspal hematoma).
  • Obstruction of blood circulation to the heart resulting in damage to the heart tissue (myocardial infarction).

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


Mosaic Valve

The Mosaic valve is used to replace your heart's natural valve when it has become diseased or weakened by age. It can also be used to replace your prosthetic valve when it is no longer working properly. (A prosthetic valve is a replacement valve made of human, animal, or artificial materials.)

Valve replacement can include the following risks:

  • Angina.
  • Abnormal heart beat (cardiac arrythmia and dysrhythmia).
  • Blood leaking around the outside of the prosthetic valve (paravalvular leak) or any problem with the valve that causes leaking of blood after the valve has closed (transvalvular leak).
  • Damage to red blood cells (hemolysis) that can result in anemia.
  • Death.
  • Inflammation of the lining of the heart (endocarditis).
  • Heart failure.
  • Any problem with the prosthetic valve that causes narrowing of the valve opening (stenosis).
  • Blood clots that develop in the heart or on the replacement valve. These clots may break loose and travel through the bloodstream (thromboembolism). This problem may cause a stroke or heart attack.
  • Obstruction of blood circulation to the heart resulting in damage to the heart tissue (myocardial infarction).

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


Hancock II Valve

The Hancock II valve is used to replace your heart's natural valve when it has become diseased or weakened by age. It can also be used to replace your prosthetic valve when it is no longer working properly. (A prosthetic valve is a replacement valve made of human, animal, or artificial materials.)

Valve replacement can include the following risks:

  • Angina.
  • Abnormal heart beat (cardiac arrythmia and dysrhythmia).
  • Blood leaking around the outside of the prosthetic valve (paravalvular leak) or any problem with the valve that causes leaking of blood after the valve has closed (transvalvular leak).
  • Damage to red blood cells (hemolysis) that can result in anemia.
  • Death.
  • Inflammation of the lining of the heart (endocarditis).
  • Heart failure.
  • Any problem with the prosthetic valve that causes narrowing of the valve opening (stenosis).
  • Blood clots that develop in the heart or on the replacement valve. These clots may break loose and travel through the bloodstream (thromboembolism). This problem may cause a stroke or heart attack.
  • Obstruction of blood circulation to the heart resulting in damage to the heart tissue (myocardial infarction).

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


Duran AnCore Annuloplasty System

The Duran AnCore annuloplasty ring or band is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty ring or band is a loop or band of material made of durable artificial materials.)

The Duran AnCore System should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).

Valve repair procedures may include, but are not limited to the following risks:

  • Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis).
  • Damage to red blood cells (hemolysis).
  • Any problem with the band or ring that causes narrowing of the valve opening (stenosis).
  • Small amounts of blood leaking through the valve opening even after it closes.
  • Abnormal heart beat (dysrhythmia).
  • Inflammation of the lining of the heart (endocarditis).
  • Anticoagulant-related bleeding or hemorrhage.

This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.

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


CG Future Annuloplasty System

The CG Future Ring or Band is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

The CG Future Ring or Band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).

Valve repair procedures may include, but are not limited to the following risks:

  • Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis).
  • Damage to red blood cells (hemolysis).
  • Any problem with the band or ring that causes narrowing of the valve opening (stenosis).
  • Small amounts of blood leaking through the valve opening even after it closes.
  • Abnormal heart beat (dysrhythmia).
  • Inflammation of the lining of the heart (endocarditis)
  • Anticoagulant-related bleeding or hemorrhage.

This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.

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


AOA and Physiologic Fixation Statement

No clinical data are available which evaluate the long-term impact of AOA treatment and the Physiologic Fixation process in patients.


Contegra (FOR HDE USE)

CONTEGRA Pulmonary Valved Conduit

Indications: See *Humanitarian Use Device section below.

Contraindications: None known.

Warnings/Precautions/Side Effects:

Acceptable clinical performance has been established for the CONTEGRA conduit in pediatric patients under the age of 10. Because of the possibility that complications of the device could become apparent only after extended use, a benefit – risk consideration of the long-term use of the CONTEGRA conduit in pediatric patients over 10 years of age is particularly important. General complications reported with valved conduits and biological tissue valves implanted in the heart include: hemorrhage, bleeding diathesis due to use of anticoagulants, residual or increasing transvalvular gradients, progressive neointimal thickening and peeling, progressive stenosis and obstruction, progressive pulmonary hypertension, graft infection, endocarditis, regurgitation, hemolysis, valve malfunction, physical or chemical deterioration, thromboembolism, thrombus, conduit dilatation.

For additional information, please refer to the Instructions For Use provided with the product.

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

*Humanitarian Use Device:

Authorized by Federal law for use in patients under 18 years of age for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in the following congenital heart malformations: Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition with Ventricular Septal Defect (VSD), Pulmonary Atresia. In addition, the CONTEGRA Pulmonary Valved Conduit is indicated for the replacement of previously implanted but dysfunctional pulmonary homografts or valved conduits. The effectiveness of this device for these uses has not been demonstrated.


Profile 3D™ Annuloplasty System

The Profile 3D ring may be used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty ring is made of durable artificial materials.)

The Profile 3D ring should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).

Valve repair procedures may include, but are not limited to the following risks:

  • Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis).
  • Damage to red blood cells (hemolysis).
  • Any problem with the ring that causes narrowing of the valve opening (stenosis).
  • Small amounts of blood leaking through the valve opening even after it closes.
  • Abnormal heart beat (dysrhythmia).
  • Inflammation of the lining of the heart (endocarditis)
  • Anticoagulant-related bleeding or hemorrhage.

This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.

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


Medtronic Open Pivot™ Heart Valves

Indications: Medtronic Open Pivot™ heart valves are used to replace your heart's natural valve when it has become diseased or weakened by age. It can also be used to replace your prosthetic valve when it is no longer functioning properly. (A prosthetic valve is a replacement valve made of human, animal, or artificial materials.)

Contraindications: These valves should not be used in patients who cannot tolerate long-term anticoagulation therapy.

Adverse Events: Valve replacement procedures may include, but are not limited to the following risks:

  • Abnormal heart beat (dysrhythmia)
  • Death
  • Failure of the valve to open and close properly
  • Infection
  • Damage to red blood cells (hemolysis)
  • Hemorrhage
  • Blood leaking across the valve or between the valve and the patient's tissue (transvalvular leak/paravalvular leak)
  • Blood clot formation on or around the valve; these blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
  • Valve dysfunction

This list is not inclusive of all risks. Talk to your physician regarding more information about valve replacement surgery.

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


Medtronic Open Pivot™ Aortic Valved Graft

Indications
Medtronic Open Pivot™ Aortic Valved Graft is used to replace your heart's natural aortic valve and ascending aorta when it has become diseased or weakened by age.

Contraindications
The Medtronic Open Pivot Aortic Valved Graft should not be used in patients who cannot tolerate long-term anticoagulation therapy or in patients with a known sensitivity to products of bovine (cattle) origin.

Adverse Events
Valve replacement procedures may include, but are not limited to the following risks:

  • Abnormal heart beat (dysrhythmia)
  • Death
  • Failure of the valve to open and close properly
  • Infection
  • Damage to red blood cells (hemolysis)
  • Hemorrhage
  • Blood leaking across the valve or between the valve and the patient's tissue (transvalvular leak/paravalvular leak)
  • Blood clot formation on or around the valve; these blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
  • Valve dysfunction

Adverse events potentially associated with the use of vascular grafts include:

  • Blood clot formation on or around the valve; these blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
  • Clinical reaction to collagen
  • Infection
  • Hemorrhage
  • Failure of the valve to open and close properly
  • Tissue swelling

This list is not inclusive of all risks. Talk to your physician regarding more information about valve replacement surgery.

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


Simulus Flexible Annuloplasty System

The Simulus flexible annuloplasty system is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

The Simulus flexible ring or band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).

Valve repair procedures may include, but are not limited to the following risks:

  • Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis).
  • Damage to red blood cells (hemolysis).
  • Any problem with the band or ring that causes narrowing of the valve opening (stenosis).
  • Small amounts of blood leaking through the valve opening even after it closes.
  • Abnormal heart beat (dysrhythmia).
  • Inflammation of the lining of the heart (endocarditis).
  • Anticoagulant-related bleeding or hemorrhage.

This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.

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


Simulus® Semi-Rigid Annuloplasty System

The Simulus® semi-rigid annuloplasty system is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

The Simulus® semi-rigid ring or band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).

Valve repair procedures may include, but are not limited to the following risks:

  • Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis).
  • Damage to red blood cells (hemolysis).
  • Any problem with the band or ring that causes narrowing of the valve opening (stenosis).
  • Small amounts of blood leaking through the valve opening even after it closes.
  • Abnormal heart beat (dysrhythmia).
  • Inflammation of the lining of the heart (endocarditis).
  • Anticoagulant-related bleeding or hemorrhage.

This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.

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