Important Safety Information for the XIENCE V coronary stent system. Instructions for Use for the XIENCE V coronary stent system.

The procedure for implanting a XIENCE V stent is performed in a cardiac catheterization laboratory (cath lab). It usually takes about 90 minutes. The doctor will ask you to remain very still. You should be comfortable but may feel some pressure or chest pain when the balloon is inflated. This is normal and will quickly fade when the balloon is deflated.

Getting started

You may be given a mild sedative to help you relax, but you will not be put to sleep. As you will lie on the table:

  • An X-ray camera will move over your chest. The staff will monitor your heart by attaching several small, sticky patches to your chest and using a specialized electrocardiogram (ECG) monitor
  • The groin is the most common site for catheter introduction and requires a small incision to be made on the inside of your upper thigh. Your doctor will insert a catheter (the guiding catheter) and advance it to where the coronary arteries branch off to the heart
  • A guide wire is then threaded through the guiding catheter and navigated to the narrowing in the coronary artery. This helps to carry all the necessary devices required during the stenting procedure

Placing the balloon and stent

After the catheters are inserted:

  • Your doctor will inject a contrast dye through the guiding catheter into your artery to view the narrowing
  • A balloon catheter is positioned and inflated in the narrowed artery. This compresses the plaque and widens the artery, which is called pre-dilation
  • The stent mounted on a balloon catheter is delivered to the narrowing in the coronary artery by a delivery catheter
  • The balloon is then inflated and this expands the stent, pressing it against the coronary artery wall. Your doctor may choose to expand the stent further by using another balloon so that the stent can make better contact with the artery wall. This is known as postdilatation

Once in place, the XIENCE V stent will remain as a permanent implant in your coronary artery.

Immediately after Procedure

You will be asked to lie flat for four to six hours following the procedure and to not bend your leg or arm, depending on which area your doctor used to insert the catheters. Pressure will also be placed on the area.

A vascular closure device may be used to seal the incision site in your groin or arm. You will be allowed to get up and walk around sooner if this type of device is used. Your hospital stay may range from one to three days.

Medications will be prescribed for you before and after stent placement. Antiplatelet medications such as aspirin and Plavix® are the most commonly prescribed. They help prevent a blood clot (thrombus) from forming and blocking the stent lumen. Your doctor or nurse will give you instructions about your medications before you leave the hospital.

CAUTION: If you have any chest pain, discomfort, or bleeding from your incision site, call your doctor immediately. If your doctor is unavailable, call for an ambulance to take you to the nearest hospital emergency room.

Take All Medications as Instructed

After you leave the hospital, your cardiologist may instruct you to take a daily dose of aspirin and another antiplatelet drug such as Plavix®. Your doctor will tell you how long you should continue taking the antiplatelet drugs. It is very important that you take these medications exactly as your doctor instructs you:

  • Follow your medication schedule exactly to avoid possible complications after you receive your stent. Do not miss any doses.
  • Call your doctor if you cannot keep taking your medications because of side effects such as rash, bleeding, or upset stomach.
  • CAUTION: Do not stop taking your prescribed medications unless you are instructed to do so by the doctor who performed your stent procedure.
  • CAUTION: Notify your cardiologist or family doctor if you are scheduled to see the dentist while on antiplatelet medication. Your doctor may prescribe antibiotics to avoid the potential of an infection. You should review with your doctor any recommendations from your dentist to stop your prescribed medications.
  • CAUTION: Before undergoing implantation of a drug-eluting stent, if you plan to have any type of surgery, which may require you to stop taking antiplatelet medications, you and your cardiologist should discuss whether or not placement of a drug-eluting stent is the right treatment choice for you.

If surgery or dental work, which would require you to stop taking antiplatelet medications, is recommended after you’ve received the stent, you and your doctors should carefully consider the risks and benefits of this surgery or dental work versus the possible risks from early discontinuation of these medications.

If you do require discontinuation of antiplatelet medications because of significant bleeding, your cardiologist will carefully monitor you for possible complications. Once your condition has stabilized, your cardiologist may put you back on these medications.

Follow-Up Care

You will be discharged to the care of your cardiologist or family doctor. You should be able to return to your normal activities soon.

CAUTION: Notify your doctor immediately if you experience chest pain (angina), or notice any changes such as more severe or frequent chest discomfort, especially in the first month after a procedure. These symptoms may indicate a renarrowing in your coronary arteries.

Your doctor will ask you to return for follow-up visits. The first visit is usually two to four weeks after your stent is implanted, with follow-up visits every six months for the first year. Be sure to keep all appointments for follow-up care, including blood tests.

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1Plavix is a registered trademark of Sanofi-Synthelabo.

2Ticlid is a registered trademark of Roche Pharmaceuticals.



The XIENCE™ V Everolimus Eluting Coronary Stent on the MULTI-LINK MINI-VISION® or MULTI-LINK VISION® Delivery System

INDICATIONS
The XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V stent) is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.


CONTRAINDICATIONS
The XIENCE V stent is contraindicated for use in patients:

  • Who cannot receive antiplatelet and/or anti-coagulant therapy
  • With lesions that prevent complete angioplasty balloon inflation or proper placement of the stent or stent delivery system
  • With hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, and fluoropolymers.

WARNINGS

  • Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
  • Judicious patient selection is necessary because device use has been associated with 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

  • 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 is accessible.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent is presently unknown.
  • Risks and benefits should be considered in patients with severe contrast agent allergies.
  • Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Use fluoroscopy to avoid arterial damage.
  • Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Stent thrombosis is frequently associated with myocardial infarction (MI) or death.
  • When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the XIENCE V SPIRIT family of trials.
  • Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
  • Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.
  • A patient’s exposure to drug and polymer is proportional to the number of and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.
  • Safety and effectiveness of the XIENCE V stent have not been established for subject populations with the following clinical settings:
    • Patients with prior target lesion or in-stent restenosis related brachytherapy, patients in whom mechanical atherectomy devices or laser angioplasty devices are used simultaneously, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.5 mm or > 4.25 mm or lesion lengths > 28 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, chronic total occlusions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent acute myocardial infarction (AMI) or evidence of thrombus in target vessel, moderate or severe lesion calcification, multivessel disease, in-stent restenosis, and patients with longer than 24 months follow-up
  • Everolimus has been shown to reduce the clearance of some prescription medications when it was administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE V stent because of limited systemic exposure to everolimus eluted from XIENCE V.
  • Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
  • Oral everolimus use in renal transplant patients was associated with increased serum cholesterol and triglycerides that in some cases required treatment.
  • Non-clinical testing has demonstrated that the XIENCE V stent, in single and in overlapped configurations up to 68 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.
  • The XIENCE V stent should be handled, placed, implanted, and removed according to the Instructions for Use.

POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order) which may be associated with coronary stent use in native coronary arteries include but are not limited to:

  • Abrupt closure, Access site pain, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to contrast agent or cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers; and drug reactions to antiplatelet drugs or contrast agent, Aneurysm, Arterial perforation and injury to the coronary artery, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Distal emboli (air, tissue or thrombotic), Emergent or non-emergent coronary artery bypass graft surgery, Fever, Hypotension and / or hypertension, Infection and pain at insertion site, Injury to the coronary artery, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia (due to vascular injury), Pseudoaneurysm, Renal Failure, Restenosis of the stented segment of the artery, Shock/pulmonary edema, Stroke / cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular complications including at the entry site which may require vessel repair, Vessel dissection

Adverse events associated with daily oral administration of everolimus to organ transplant patients include but are not limited to:

  • Abdominal pain, Acne, Anemia, Coagulopathy, Diarrhea, Edema, Hemolysis, Hypercholesterolemia, Hyperlipidemia, Hypertension, Hypertriglyceridemia, Hypogonadism male, Infections: wound infection, urinary tract infection, pneumonia, pyelonephritis, sepsis and other viral, bacterial and fungal infections, Leukopenia, Liver function test abnormality, Lymphocele, Myalgia, Nausea, Pain, Rash, Renal tubular necrosis, Surgical wound complication, Thrombocytopenia, Venous thromboembolism, Vomiting

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.