Page 10 - Edwards SAPIEN 3 Ultra Implanter Brochure

failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, atrium,
septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or
renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula
or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; left ventricular outflow tract obstruction; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture
line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; injury to the mitral valve; device explants; mediastinitis; mediastinal bleeding; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.
Edwards Axela Sheath
Indications: The Edwards Axela sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Ultra delivery system.
Contraindications: There are no known contraindications.
Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.
Precautions: Caution should be used in vessels that have diameters less than 5.5 mm as it may preclude safe placement of the 14F Edwards Axela sheath. For subclavian/axillary vessels with the 29 mm Edwards SAPIEN 3 Ultra delivery system, caution should be used in vessels that have diameters less than 6.0 mm as it may preclude safe placement of the 14F Edwards Axela sheath. Use caution in tortuous or calcified vessels that would prevent safe entry of the sheath. Do not use the Edwards Axela sheath if the packaging sterile barriers and any components have been opened or damaged or the expiration date has elapsed. When inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position. When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.
Potential Adverse Events: Complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, hemorrhage, infection, and/or death.
Edwards eSheath
Indications: The Edwards eSheath introducer set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the
Edwards SAPIEN 3 Ultra transcatheter heart valves.
Contraindications: There are no known contraindications.
Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. The Edwards eSheath introducer set must be used with a compatible 0.035” (0.89 mm) guidewire to prevent vessel injury.
Precautions: Caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F Edwards eSheath introducer set respectively. Use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set. Do not use the Edwards eSheath introducer set if the packaging sterile barriers and any components have been opened or damaged. When inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position. When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.
Potential Adverse Events: Complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, hemorrhage, infection, and/or death.
Edwards Crimper
Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 Ultra transcatheter heart valve and the Edwards SAPIEN 3
transcatheter heart valve for implantation. Contraindications: There are no known contraindications.
Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.
Precautions: For special considerations associated with the use of the Edwards crimper prior to THV implantation, refer to the THV Instructions for Use. Potential Adverse Events: There are no known potential adverse events associated with the Edwards crimper.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.
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Edwards SAPIEN 3 Ultra, eSheath, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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