Indications for Use
For use in right heart reconstructive procedures for the repair of congenital or acquired cardiac and great vessel malformations or pathology.
Contraindications
Patients undergoing chronic hemodialysis have an increased tendency towards calcification of tissue valved conduits.
Warnings/Precautions/Adverse Events
Preclot valved conduits to minimize hemorrhage through the conduit. Reported complications include: valvular thrombosis, thromboembolism, cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, anticoagulant/antiplatelet-related leak, transvalvular or paravalvular, nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), structural deterioration (calcification, leaflet tear, stenosis, other), development of intraluminal peel, hemorrhage through the graft and anastomotic sites.
For additional information, please refer to the Instructions For Use provided with the product.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.