IMPORTANT SAFETY INFORMATION AORTIC AND MITRAL VALVE REPLACEMENT


Avalus Bioprosthesis

Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.  

Contraindications: None known.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural 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, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Caution: Federal law (USA) restricts this device 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 www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.


MOSAIC BIOPROSTHESIS

Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart 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, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, 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, consult instructions for use at www.medtronic.com/manuals. Note: Manuals can be viewed 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/or mitral 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, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, 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, consult instructions for use at www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.


FREESTYLE AORTIC ROOT BIOPROSTHESIS

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

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: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma.

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.

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

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


MEDTRONIC OPEN PIVOT HEART VALVES

Important Labeling Information for United States

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.

Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device.

Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. 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.

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.


MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT

Important Labeling Information for United States

Indications: The Medtronic Open Pivot™ Aortic Valved Graft (AVG) 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 AVG 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 heart 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.

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.