On-X^® Prosthetic Heart Valve

 

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.

 

Contraindications (Who should not use):

The On-X Prosthetic Heart Valve is contraindicated for patients unable to tolerate anticoagulation therapy (blood thinner medications).

The safety and effectiveness of the On-X Prosthetic Heart Valve has not been established for the following specific populations because it has not been studied in these populations:

• patients who are pregnant;
• nursing mothers;
• patients with chronic endocarditis;
• patients requiring pulmonary or tricuspid replacement.

 

Warnings:

For single use only. Surgeon should not use the On-X Prosthetic Heart Valve if:

• the prosthesis has been dropped, damaged, or mishandled in any way;
• the expiration date has elapsed;
• the tamper evident seal is broken;
• the serial number tag does not match the serial number on the container label.

Surgeon should not pass a catheter, surgical instrument, or transvenous pacing lead through the prosthesis as this may cause valvular insufficiency, leaflet damage, leaflet dislodgment, and/or catheter/instrument/lead entrapment.

Surgeon should not resterilize the On-X Prosthetic Heart Valve.

 

Precautions:

Surgeon should handle the prosthesis with only On-X Life Technologies, Inc. (On-XLTI) On-X Prosthetic Heart Valve Instruments. Only On-XLTI On-X Prosthetic Heart Valve sizers should be used during the selection of the valve size; other sizers may result in improper valve selection.

Surgeon should avoid contacting the carbon surfaces of the valve with gloved fingers or any metallic or abrasive instruments as they may cause damage to the valve surface not seen with the unaided eye that may lead to accelerated valve structural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.

Surgeon should avoid damaging the prosthesis through the application of excessive force to the valve orifice or leaflets.

 

Potential Adverse Events:

Adverse events potentially associated with the use of prosthetic heart valves (in alphabetical order) include, but are not limited to:

• angina (chest pain)
• cardiac arrhythmia (irregular heart beat)
• endocarditis (infection within the heart)
• 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)
• 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.

 

010122 77 E (2020-12)