Indications, Safety, and Warnings Heart Valve Replacement - Surgical

Tissue Heart Valves

Freestyle Bioprosthesis

Indications: For the replacement of malfunctioning native or prosthetic aortic valves with theoption of aortic root replacement.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcificdegeneration of bioprosthesis may occur in: children, adolescents, young adults, and patientswith altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverseevents can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage,transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration,thromboembolism, valve thrombosis, or intracuspal hematoma.

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 adverseevents, please refer to the Instructions for Use. For countries that use eIFUs, consultinstructions for use at this website www.medtronic.com/manuals. Note: Manuals can beviewed using a current version of any major internet browser.

Mosaic Bioprosthesis

Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitralheart valves.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in:children, adolescents, young adults, and patients with altered calcium metabolism (e.g.,chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiacarrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolyticanemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructuraldysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

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 adverseevents, please refer to the Instructions for Use. For countries that use eIFUs, consultinstructions for use at this website www.medtronic.com/manuals. Note: Manuals can beviewed using a current version of any major internet browser.

Hancock II Bioprosthesis

Indications: For patients who require replacement of their native or prosthetic aortic and/ormitral valves.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in:children, adolescents, young adults, and patients with altered calcium metabolism (e.g.,chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiacarrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolyticanemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructuraldysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

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, consultinstructions for use at this website www.medtronic.com/manuals. Note: Manuals can beviewed using a current version of any major internet browser.

Mechanical Heart Valves

Medtronic Open Pivot Mechanical Heart Valves

Indications: The Medtronic Open Pivot™ Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.

Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.

Potential Adverse Events: Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.

CAUTION: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions.

Medtronic Open Pivot Aortic Valved Graft (AVG)

Indications: The Medtronic Open Pivot™ Aortic Valved Graft is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.

Contraindications: The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. The Hemashield® Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement.

Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin.

Potential Adverse Events: Certain complications may occur with heart valve procedures. The adverse events potentially associated with the use of prosthetic aortic valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism.

Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma.

It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.

CAUTION: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.