Important Risk Information
Important Risk Information for Transcatheter Pulmonary Valve Replacement for the Edwards SAPIEN 3 Transcatheter Heart Valve System with the Edwards Commander Delivery System
Indications:
The Edwards SAPIEN 3 transcatheter heart valve (THV) system with the 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:
- 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.
- 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.
Important Risk Information for Transcatheter Pulmonary Valve Replacement with the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System and Alterra Adaptive Prestent
Indications:
The Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent is a minimally invasive treatment option, designed to help treat severe pulmonary regurgitation in children, adolescents, and adults with a native or surgically repaired right ventricular outflow tract (RVOT).
Contraindications (Who should not use):
The Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent should not be used with anyone who cannot tolerate medications that thin the blood or prevent blood clots from forming or who have an active infection in the heart or elsewhere.
Potential risks associated with the procedure include:
As with any medical procedure, there is a possibility of side effects or complications. The most serious risks from the Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent, although rare, are death and stroke.
Other possible risks associated with the procedure include:
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, blood clot in a deep vein, device movement after deployment requiring reintervention, device 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, abnormal lab values, high or low blood pressure, formation of a blood clot, bleeding under the skin, allergic reaction to anesthesia or dye, fainting, pain, weakness or inability to exercise, swelling, chest pain or fever.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.
Important Risk Information for Transcatheter Pulmonary Valve Replacement for the Edwards SAPIEN 3 Transcatheter Heart Valve System with the Edwards Commander Delivery System
Indications:
The Edwards SAPIEN 3 transcatheter heart valve (THV) system with the 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:
- 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.
- 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.
Important Risk Information for Transcatheter Pulmonary Valve Replacement with the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System and Alterra Adaptive Prestent
Indications:
The Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent is a minimally invasive treatment option, designed to help treat severe pulmonary regurgitation in children, adolescents, and adults with a native or surgically repaired right ventricular outflow tract (RVOT).
Contraindications (Who should not use):
The Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent should not be used with anyone who cannot tolerate medications that thin the blood or prevent blood clots from forming or who have an active infection in the heart or elsewhere.
Potential risks associated with the procedure include:
As with any medical procedure, there is a possibility of side effects or complications. The most serious risks from the Edwards SAPIEN 3 transcatheter pulmonary valve system and Alterra adaptive prestent, although rare, are death and stroke.
Other possible risks associated with the procedure include:
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, blood clot in a deep vein, device movement after deployment requiring reintervention, device 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, abnormal lab values, high or low blood pressure, formation of a blood clot, bleeding under the skin, allergic reaction to anesthesia or dye, fainting, pain, weakness or inability to exercise, swelling, chest pain or fever.