The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL, XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTILINK VISION® or MULTI-LINK MINI VISION® Delivery System

_INDICATIONS

_{The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.}

_{CONTRAINDICATIONS}

_{The XIENCE Sierra stent system is contraindicated for use in:}

• _{Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.}
• _{Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.}

_WARNINGS

• _{It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.}
• _{Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.}
• _{This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.}

_PRECAUTIONS

• _{Ensure that the inner package sterile barrier has not been opened or damaged prior to use.}
• _{Stent implantation should only be performed by physicians who have received appropriate training.}
• _{Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.}
• _{Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.}
• _{Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.}
• _{When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.}
   

^{CAUTION: This product is intended for use by or under the direction of a physician. Prior to use,
reference the Instructions for Use, inside the product carton (when available) or at
eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications,
Contraindications, Warnings, Precautions and Adverse Events.}

^{Abbott
3200 Lakeside Dr., Santa Clara, CA 95054 USA, Tel: 1.800.227.9902}

^{www.cardiovascular.abbott
©2019 Abbott. All rights reserved. AP2947781-WBU Rev. A}