Safety Information for On-X Prosthetic Heart Valves and On-X Ascending Aortic Prosthesis
The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions.1 The On-X Ascending Aortic Prosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic heart valve in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.2
The adverse events potentially associated with the use of prosthetic heart valves and aortic valved grafts include, but are not limited to angina, cardiac arrhythmia, endocarditis, excessive blood loss through the graft, false aneurysm, graft infection, graft occlusion or kinking, heart failure, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, prosthesis leaflet entrapment (impingement), prosthesis nonstructural dysfunction, prosthesis pannus, prosthesis perivalvular leak, prosthesis regurgitation, prosthesis structural dysfunction, prosthesis thrombosis, secondary fistula formation, stroke, and thromboembolism. It is possible that these complications could lead to reoperation, explantation, permanent disability, or death.1,2
Anticoagulation, or blood thinner, medication is required for mechanical valve patients.
Each patient’s individual health risks should be evaluated by a health care professional. Potential risks associated with prosthetic heart valves are dependent upon the patient’s age, overall health, heart function, and any additional medical conditions.
To further discuss the safety information for On-X Prosthetic Heart Valves and On-X Ascending Aortic Prosthesis, please email info[@]heartvalvechoice.com.
- On-X Prosthetic Heart Valve Instructions for Use.
- On-X Ascending Aortic Prosthesis Instructions for Use.