Indications, Safety, and Warnings

Indications

The 3f^® Aortic Bioprosthesis, Model 1000, is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

Contraindications

The 3f^® Aortic Bioprosthesis, Model 1000, should not be used in those patients who present with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.

Warnings/Precautions/Side Effects

Accelerated deterioration of the Model 1000 valve due to calcific degeneration may occur in children, adolescents, or young adults, or in patients with altered calcium metabolism such as patients on maintenance hemodialysis for chronic renal failure, patients with hyperparathyroidism, patients on high calcium diets, or patients requiring chronic calcium-containing drug therapy. The performance of the Model 1000 valve is, as is the case for all stentless bioprosthetic valves, dependent on accurate matching of the valve to the recipient patient’s aortic annular and sinotubular dimensions and may be adversely affected by high aortic root compliance. General complications potentially associated with the use of bioprosthetic heart valves include: leak (transvalvular, perivalvular), cardiac dysrhythmias, endocarditis, hemolysis, hemorrhage, non-structural dysfunction [NSD] (entrapment by pannus or suture, inappropriate sizing or positioning, or other), structural deterioration (intrinsic and extrinsic calcification, leaflet perforation or tear, leaflet thickening, or myxomatous degeneration), prosthesis stenosis, prosthesis regurgitation, valve thrombosis, thromboembolism.

CAUTION: Federal law restricts this device to sale by or on the order of a physician. This device is restricted to use by a physician who has participated in specific implantation training for the 3f^® Aortic Bioprosthesis, Model 1000.