Edwards EVOQUE Tricuspid Valve Replacement System


Who can be treated:

The EVOQUE tricuspid valve replacement system (the EVOQUE system) is  approved for treating patients with symptomatic severe tricuspid  regurgitation (TR) for the improvement of health status. TR is a  condition in which the tricuspid valve on the right side of the heart  doesn't close properly.  When the valve does not fully close, blood  flows backward from the lower chamber (ventricle) into the upper chamber (atrium) making the patient's heart work harder to move blood through  the valve.  Patients should work with their doctor and a specialized  Heart Team to determine if the patient is a suitable candidate for the  EVOQUE valve.

Who should not use:

The EVOQUE system should not be used in patients who:

• Cannot take blood thinning medications
• Have an active infection in the heart or elsewhere
• Have an untreatable allergy to nickel or titanium

If used in the patients mentioned above, it will not work properly and could make you feel sick or even cause death.

Warnings:

How long your tissue valve will last depends on many patient factors and  medical conditions. Follow all care instructions to ensure the best  possible results. The Edwards EVOQUE valves have been tested in a  laboratory to mimic 5 years of use without failure. Regular follow-ups  will help your doctor know how your EVOQUE valve is working.

• Follow all care instructions to ensure the best possible results.  Regular follow-up is advised to evaluate the performance of your device
• Blood thinning medication may be necessary after valve replacement with the EVOQUE system.  Your doctor should prescribe this and other medical therapy per standard guidelines.

The safety and effectiveness of the transcatheter heart valve is not known for patients:

• Who are dependent on their pacemaker without other pacing options
• Who had a pacemaker implanted within the last 3 months before the valve implantation procedure
• Who have severe pulmonary hypertension not managed by medication
• Who have severe right ventricular dysfunction


Precautions:

Precautions Prior to Use

Seeing a specialized doctor on a Heart Team will ensure you are evaluated for  all treatment options. They will consider factors about your health to  decide the most appropriate treatment option for you.

Your doctor will consider these factors:

• Your medical history
• Your age
• Your current health status
• Your ability to undergo the procedure and recover from it
• The overall condition of your heart

General Precautions

• Problems with the electrical pathway of your heart that require a  pacemaker may occur before, during, or following implantation of the  EVOQUE valve
• Talk to your doctor about risk of infection and  needing antibiotics if you require a dental procedure after your heart  valve replacement
• Long-term durability has not been established for the EVOQUE valve. Clinical data is reflective of short-term  follow-up, and regular medical follow-up is advised

Potential Risks

As with any medical procedure, there is a possibility of risks.

The most serious risks associated with the procedure are:

• Death
• Stroke
• Serious bleeding (with the potential to be given blood)
• Problems with the electrical pathway of your heart that requires a pacemaker
• Unplanned repeat procedure, hospitalization, or surgery
• Major vascular complications
• Permanent disability

Additional potential risks include:

• Abnormal lab values
• Abnormal low or high blood pressure
• Additional cardiac surgery, vascular surgery, or intervention, including removal of the transcatheter heart valve
• Allergic reaction
• Anemia
• Blood leak around the valve
• Chest pain
• Collection of fluid or blood around your heart
• Damage to blood cells
• Damage to the swallowing passage (esophagus), with possible puncture or narrowing
• Damage to the valve or deterioration (wear, tear, fracture, leaflet  thickening, stenosis), malposition, clotting, movement or embolization  of the valve, which might require removal of the valve
• Failure to retrieve any EVOQUE system components
• Fluid buildup in your lungs
• Having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve
• Heart attack or heart failure/decreased heart pumping
• Incorrect position of valve or valve movement
• Infection in your heart, blood, or other areas
• Interference/damage with an existing permanent pacemaker or defibrillator
• Irregular heart rate
• Kidney failure
• Nausea and/or vomiting
• Nerve injury, paralysis or neurological symptoms, including problems with movement or walking
• Organ failure, including heart failure
• Pain, inflammation, or fever
• Right ventricular outflow tract (RVOT) obstruction
• Severe bleeding or fluid in or around the heart or in the body that could require a transfusion or surgery
• Skin burn, injury or tissue changes due to exposure to X-rays
• Sudden or unexpected loss of heart function
• Swelling
• Trouble or inability to breathe
• Valve regurgitation (new or worsening tricuspid, aortic, mitral, or pulmonary)

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.