Indications, Safety, and Warnings

Avalus™ Bioprosthesis

Indications, Safety, and Warnings

Avalus™ Bioprosthesis

Important Labeling Information for United States

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.

Important Labeling Information for Europe

Indications for Use: The Avalus bioprosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve for patients 70 years of age and older.
Contraindications: Do not use the valve if its use is not in the best interest of the patient. Evaluate all of the risks involved, including the anatomy and pathology observed at the time of surgery.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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 dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, stenosis, other), thromboembolism, and valve thrombosis. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

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.

Important Labeling Information for Other Geos

Indications for Use: The Avalus bioprosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Contraindications: Do not use the valve if its use is not in the best interest of the patient. Evaluate all of the risks involved, including the anatomy and pathology observed at the time of surgery.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. 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 dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, stenosis, other), thromboembolism, and valve thrombosis. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

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.