Mosaic® Porcine Bioprosthesis
Indications, Safety and Warnings
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.
Contraindications: This device is not intended for use except as indicated. 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 this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
For further information, please call Medtronic at (877) 526-7890 or visit www.medtronic.com.
