Indications for Use
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.
Warnings/Precautions/Adverse Events
Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.
Caution
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions.