Indications, Safety, and Warnings Heart Valve Repair - Surgical

• CG Future™ Annuloplasty System
• Contegra Pulmonary Valved Conduit
• Contour™ 3D Tricuspid Annuloplasty Ring
• Duran™ AnCore Annuloplasty System
• Hancock Porcine Valved Conduits
• Profile™ 3D Annuloplasty System
• Simulus™ Semi-Rigid Annuloplasty Ring and Bands
• Simulus™ Flexible Annuloplasty System
• Tri-Ad™ Adams Annuloplasty Ring

CG Future Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

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

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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.

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Contour™ 3D Tricuspid Annuloplasty Ring

Indications: The Contour 3D ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, right ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.

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Duran AnCore Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Note: The Chordal Guide feature of the Duran AnCore^® Ring/Band with Chordal Guide is indicated only for chordal replacement surgery of pathological mitral valves.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

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

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Hancock Porcine Valved Conduits

Indications: For use in reconstructive procedures for the repair of congenital or acquired cardiac and great vessel malformations or pathology.

Contraindications: Patients undergoing chronic hemodialysis have an increased tendency towards calcification of tissue valved conduits.

Warnings/Precautions/Adverse Events: Preclot valved conduits to minimize hemorrhage through the conduit. Reported complications include: valvular thrombosis, thromboembolism, calcification and fibrosis, valvular insufficiency, perivalvular insufficiency, valvular stenosis, leaflet perforation, significant transvalvular pressure gradients in small size bioprostheses, valve contamination, development of intraluminal peel, and hemorrhage through the graft and anastomotic sites.

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.

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Profile 3D Annuloplasty System

Indications:  This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications:  Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events:  Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage. For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

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

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Simulus Semi-Rigid Annuloplasty Ring and Band

Indications: The Simulus semi-rigid annuloplasty ring and band are for use in patients undergoing surgery for diseased or damaged mitral valves. The Simulus semi-rigid annuloplasty ring and band provide support for and restrict expansion of the annulus.

Contraindications: Severe, generalized or localized bacterial endocarditis, heavily calcified valves, greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with severely reduced mobility, congenital malformations with lack of valvular tissue.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

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

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Simulus Flexible Annuloplasty System

Indications:  The Simulus^® Adjustable Annuloplasty Ring and Band are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty ring and band provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Contraindications:

1. Severe, generalized or localized bacterial endocarditis
2. Heavily calcified valves
3. Greatly dilated annulus (not reducible by standard techniques)
4. Severe valvular dysfunction (not correctable by standard techniques)
5. Valvular retraction with severely reduced mobility
6. Congenital malformations with lack of valvular tissue

Warnings/Precautions/Adverse Events:  Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage. For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

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

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Tri-Ad™ Adams Annuloplasty Ring

Indications: Tri-Ad Adams tricuspid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged tricuspid valves. The Tri-Ad Adams tricuspid annuloplasty ring provides support for and restricts expansion of the annulus.

Contraindications: Severe, generalized or localized bacterial endocarditis, heavily calcified valves, greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with severely reduced mobility, congenital malformations with lack of valvular tissue.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, right ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.

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