Important Safety Information

On-X® Prosthetic Heart Valve
On-X® Ascending Aortic Prosthesis

Indications:

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.
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.

Contraindications (Who should not use):

The On-X Prosthetic Heart Valve is contraindicated for patients unable to tolerate anticoagulation therapy (blood thinner medications). The On-X Ascending Aortic Prosthesis is contraindicated for patients unable to tolerate anticoagulation therapy (blood thinner medication) or who exhibit sensitivity to polyester or materials of bovine origin. The safety and effectiveness of the On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis has not been established for the following specific populations because it has not been studied in these populations:

Warnings and Precautions:

Physicians may refer to the Instructions for Use (IFU) for the On-X Prosthetic Heart Valve and the On-X Ascending Aortic Prosthesis for the full list of warnings and precautions: https://www.onxlti.com/ifu/Prophylactic antibiotic treatment must be provided to all patients with prosthetic valves undergoing dental procedures or other potentially bacteremic procedures. Patients require anticoagulation or anticoagulant/antiplatelet therapy (blood thinner medications). Adequate anticoagulant or anticoagulant/antiplatelet therapy should be administered postoperatively to patients receiving the On-X Prosthetic Heart Valve or the On-X Ascending Aortic Prosthesis. Selection of an anticoagulant or anticoagulant/antiplatelet regimen is based on the particular needs of the patient, the clinical situation and established professional guidelines. Patients should be encouraged to complete the Patient Record Card provided with the prosthesis and carry it with them at all times. Patients should be informed of the use of bovine-derived materials within this device in advance of procedure.

Potential Adverse Events:

Adverse events potentially associated with the use of prosthetic heart valves or aortic valved grafts include, but are not limited to:

      • angina (chest pain)
      • cardiac arrhythmia (irregular heart beat)
      • endocarditis (infection within the heart)
      • excessive blood loss through the graf
      • false aneurysm, aneurysm graft infection
      • graft occlusion or kinking (graft blockage)
      • heart failure
      • hemolysis (red blood cell damage)
      • hemolytic anemia (disorder in which red blood cells are destroyed faster than they are made)
      • hemorrhage (bleeding)
      • myocardial infarction (heart attack
      • prosthesis leaflet entrapment (blockage of device leaflet)
      • prosthesis nonstructural dysfunction (device leakage, blockage, inappropriate sizing, etc.)
      • prosthesis pannus (excess tissue ingrowth on device)
      • prosthesis perivalvular leak (leakage around the outside of the device)
      • prosthesis regurgitation (blood flow backwards into device)
      • prosthesis structural dysfunction (mechanical failure of device)
      • prosthesis thrombosis (blood clot attached to or near device)
      • secondary fistula formation (abnormal passage or connection)
      • stroke
      • thromboembolism (blood vessel obstruction by a blood clot)

It is possible that these complications could lead to:

      • reoperation
      • explantation
      • permanent disability
      • death

Mechanical prosthetic heart valves produce audible sounds as a normal function of their operation. In some patients, these sounds may be objectionable.
https://www.onxlti.com/ifu/