Important Risk Information

Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

Indications:

The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring who are judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):

The Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System should not be used in patients who:

• Cannot tolerate medications that thin the blood or prevent blood clots from forming.
• Have an active infection in the heart or elsewhere.
• Have a mitral ring that is damaged and can no longer support the valve.

Warnings:

• There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
• If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
• Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to anesthesia, contrast media, cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
• The Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
• During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
• Patient’s creatinine level should be measured prior to the procedure.
• Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
• Injury can occur if the delivery system is not used properly.
• Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming. Patients who do not may be at increased risk of a stroke. Blood-thinning medication may increase the risk of bleeding in the brain (stroke).
• Transcatheter valve replacement is not recommended in previous mitral valve rings that are damaged or have become too rigid.

Precautions:

The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. In addition, patient age should be considered as long-term durability of the valve has not been established. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. Patients should be treated post-procedure for heart infection as a precaution.

The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:

• An aortic heart valve that is not calcified, contains only one leaflet, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
• Who have a prosthetic ring in the tricuspid position.
• A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
• Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
• Diseased, abnormal, or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for the delivery devices, or a large amount of calcification at the point of entry.
• Allergies to blood-thinning medications or dye injected during the procedure.
• Whose previously implanted artificial valve or ring is not securely in place or is damaged that could cause it to leak.
• Whose previously implanted valve or ring could block a blood vessel caused from the leaflet partially detaching.

Potential risks associated with the procedure include:

• Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
• Risks to the heart, including heart attack or heart failure, sudden loss of heart function, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
• Risks to your lungs or breathing, including difficulty breathing, fainting, dizziness, buildup of fluid in or around the lungs, weakness, or inability to exercise.
• Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin, serious damage to the arteries, severe bleeding in the heart or in the body that could require a transfusion or surgery.
• Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection, or bleeding at incision sites, or swelling.

Additional potential risks specifically associated with the use of the heart valves include:

• Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery or emergency heart surgery and possible removal of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), valve issues not related to structure (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage) or mechanical failure of the delivery system and/or accessories.

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

Important Risk Information

The Edwards SAPIEN 3 Transcatheter Heart Valve System With The Edwards Commander Delivery System - Important Risk Information for Transcatheter Pulmonary Valve Therapy

Indications:

The Edwards SAPIEN 3 transcatheter heart valve (THV) system with Edwards Commander delivery system is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with ≥ moderate regurgitation and/or a mean RVOT gradient of ≥ 35 mmHg.

Contraindications (Who should not use):

The Edwards SAPIEN 3 transcatheter heart valve and delivery system cannot be used in patients who:

• Cannot tolerate medications that thin the blood or prevent blood clots from forming.
• Have an active infection in the heart or elsewhere.

Warnings:

• If an incorrect size of the valve is implanted, it may lead to valve leakage, movement, or dislodgement of the valve from where it was implanted, residual gradient and/or tearing of the conduit
• Patients with a disease that results in more calcium in their blood may have early wear of their valve.
• Patients should be evaluated prior to treatment for coronary compression risk.
• Talk to your doctor if you are allergic to the materials used during the procedure: cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
• X-ray used during the procedure may cause radiation injury to the skin.

Precautions:

How long the Edwards SAPIEN 3 tissue valve will last depends on many patient factors and medical conditions. Follow all care instructions to ensure the best possible results. The Edwards SAPIEN 3 pulmonic valve has been tested in a laboratory to mimic 5 years of use without failure. Regular follow-ups will help your doctor know how your valve is working.

• Patients should be pretreated for heart infection as a precaution.
• Transcatheter heart valve patients should stay on blood-thinning medicine as specified by their doctor.
• Patient’s anatomy should be evaluated prior to procedure to prevent the risk of patient not being able to receive the valve.
• The safety and effectiveness of the transcatheter heart valve have not been established for patients who:
• Have a disease or disorder of the blood (low white or red blood cell count, low platelets or history of slow blood clotting)
• Have an allergy to blood-thinning medications or dye injected during the procedure
• May be pregnant

Potential risks associated with the procedure include:

Death; stroke; risks to the lungs including: difficulty breathing, buildup of fluid in or around the lungs, collapsed lung, loss of lung volume; risks to the heart including: injury to the heart, arteries, heart muscle or valves including the pulmonary RVOT that may require intervention, heart attack, heart failure or heart does not pump properly, irregular heartbeat that may result in a need for a permanent pacemaker, too much fluid around the heart, sudden loss of heart function, disruption or blockage of blood flow through the heart, infection of the heart, injury to your tricuspid valve, additional heart surgery; dislodgement of calcified material, air embolism (air bubbles in the blood vessels), blood clots, or pieces of the device; injury to blood vessels; valve movement after deployment requiring reintervention; transcatheter valve not working properly; life-threatening infection; poor kidney function or failure; abnormal connection between an artery and vein; nerve injury; limited blood supply; severe bleeding requiring transfusion; decrease in red blood cells including at a fast rate; formation of a blood clot; abnormal lab values; high or low blood pressure; allergic reaction to anesthesia or dye; fainting; pain; weakness or inability to exercise; swelling; chest pain; fever

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

Important Risk Information

MITRIS RESILIA Mitral Valve

Indications:

For use in replacement of native or prosthetic mitral heart valves.

Contraindications:

There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects:

Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information.

Important Risk Information

Edwards PASCAL Precision Transcatheter Valve Repair System

Who can be treated:

The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is approved for treating patients with abnormality of the mitral valve leaflets and/or its structure, which may be referred to as Degenerative Mitral Regurgitation or Primary Mitral Regurgitation. Patients should work with their doctor and a specialized Heart Team, which should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to confirm their surgical risk. The specialized Heart Team will determine if the patient is a suitable candidate for the PASCAL procedure.

Who should not use:

The PASCAL Precision system should not be used in patients who:

• Cannot tolerate certain blood thinners during or after the procedure
• Have an untreatable allergy to nickel, titanium or X-ray contrast media
• Have an active infection of the mitral valve (endocarditis)
• Have mitral regurgitation caused by rheumatic disease
• Have evidence of blood clots in the heart or veins leading to the heart

Warnings:

• Serious complications, sometimes leading to surgical intervention and/or death, may be associated with the use of this system. Talk to your doctor for a full explanation of the benefits and risks associated with this procedure.
• As with any implanted medical device, there is potential for an adverse allergic or immunological response.
• Careful and continuous medical follow-up is advised so that any complications can be diagnosed and properly managed.
• Blood thinning medication will be determined by your doctor per standard guidelines.
• The PASCAL Precision system has not been evaluated in pregnant women or children.

Precautions:
Precautions Prior to Use

• Your heart team will do an assessment to decide if you are a suitable candidate for this procedure.

Precautions After Use

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

Potential Risks
The most serious risks associated with the procedure are:

• Death.
• Stroke
• Serious bleeding
• Unplanned repeat procedure or surgery

Additional potential risks include:

• Abnormal heart rhythms or cardiac arrest, which may require a pacemaker
• Abnormal low or high blood pressure
• Allergic reaction to anesthetic, contrast, heparin, Nitinol (Nickel and Titanium) and/or other medications
• Aneurysm or pseudoaneurysm
• Bleeding, stomach bleeding, hemolysis, or decreased blood count, which may require transfusion
• Blood clots in the legs (Deep Vein Thrombosis)
• Blood clots, particles, catheter fragments or air in the blood vessels, lungs, body or brain
• Cardiogenic shock
• Chest pain
• Damage or puncture of the heart or blood vessels that may require surgery
• Damage, injury to, narrowing, or tearing of the mitral valve or other valve structures
• Damage to the swallowing passage (esophagus), with possible puncture or narrowing
• Dislodgement of a previous implant
• Failure to retrieve any PASCAL Precision system components
• Fever or infection, including of the heart valveg
• Fluid or blood around the heart or lungs
• Heart attack
• Implant deterioration (wear, tear, fracture or other), malposition, clotting, movement or embolization
• Kidney failure
• Lab values that are not normal
• Nerve injury, paralysis or neurological symptoms, including problems with movement or walking
• Organ failure, including heart failure
• Pain
• Respiratory compromise that may require prolonged need for a respirator
• Shortness of breath, fainting or dizziness, nausea and/or vomiting, swelling, weakness, diminished exercise ability
• Skin burn, injury or tissue changes due to exposure to X-rays
• Single leaflet device attachment (SLDA)
• Vascular injury or trauma, including decreased blood flow, dissection or occlusion
• Worsening of valvular insufficiency
• Wound healing infection or slow healing

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

Important Risk Information

HemoSphere Monitor

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, Commander, Edwards Commander, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, HemoSphere, Life is Now, MITRIS, MITRIS RESILIA, NewHeartValve.com, PASCAL, PASCAL Precision, PERI, PERIMOUNT, Reach for the Heart, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

© 2023 Edwards Lifesciences Corporation. All rights reserved