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See Humanitarian Use Device section below.
Acceptable clinical performance has been established for the Contegra conduit in pediatric patients under the age of 10. Because of the possibility that complications of the device could become apparent only after extended use, a benefit-risk consideration of the long-term use of the Contegra conduit in pediatric patients over 10 years of age is particularly important. General complications reported with valved conduits and biological tissue valves implanted in the heart include: endocarditis, hemolysis, hemorrhage (including anticoagulant-related hemorrhage), immunologic rejection, prosthesis calcification (intrinsic and extrinsic), prosthesis (conduit) dilatation, prosthesis (conduit) dissection, neointimal thickening, neointimal peeling/dehiscence, prosthesis regurgitation, prosthesis structural deterioration (perforation, tear, thickening, dissection, or myxomatous), prosthesis stenosis, prosthesis thrombosis, pulmonary hypertension, thromboembolism, residual or increasing transvalvular pressure gradient, obstruction of implant, pulmonary embolism, coronary artery compression.
For additional information, please refer to the Instructions For Use provided with the product.
Federal law (USA) restricts this device to sale by or on the order of a physician.
Humanitarian Use Device: Authorized by federal law (USA) for use in patients under 18 years age for correction or reconstruction of the right ventricular outflow tract (RVOT) in the following congenital heart malformations: pulmonary stenosis, Tetralogy of Fallot, truncus arteriosus, transposition with ventricular septal defect (VSD), pulmonary atresia. In addition, the Contegra pulmonary valved conduit is indicated for the replacement of previously implanted but dysfunctional pulmonary homografts or valved conduits. The effectiveness of this device for these uses has not been demonstrated.
For a listing of indications, precautions, and potential side effects, please refer to the Instructions For Use provided with the product or contact your local Medtronic representative.