Indications, Safety, and Warnings Mosaic™ Mitral Bioprosthesis

Indications for use

For the replacement of malfunctioning native or prosthetic mitral heart valves.

Contraindications

None known.

Warnings, precautions, and 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, infection other than 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 (United States) restricts this device to sale by or on the order of a physician.

For a list of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use. For countries that use (electronic instructions for use) eIFUs, consult instructions for use at this website medtronic.com/manuals.