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

Contraindications

  • If you have a known hypersensitivity (allergy) or contraindication to everolimus or structurally-related compounds cobalt, chromium, nickel, tungsten, acrylic, and fluoropolymers
  • If you cannot take aspirin or blood-thinning medications (also called antiplatelet or anticoagulant therapy)
  • If your physician decides that the coronary artery blockage will not allow complete inflation of the angioplasty balloon or proper placement of the stent.

Potential Adverse Events Associated with the XIENCE V Stent

The risk of using the XIENCE V stent is similar to those that are associated with standard stent procedures. If the stent clots, you may need another angioplasty procedure. It may also lead to a heart attack, the need for urgent bypass surgery, or death. Even with successful stent implants, there is a chance of re-narrowing of your coronary artery. This may require further treatments, such as repeat angioplasty and/or bypass surgery, to reopen the artery and to increase blood flow to the heart. The risks from using balloon catheters after stent implants are similar to the risks that may occur during the initial stent implant. These may be serious enough to require surgery or cause death.

Other risks from these devices are the same as treatment procedures for a narrowed coronary artery. Some problems associated with standard balloon angioplasty and stenting include, but are not limited to:

Common Risks

  • Bruise or bleeding at the catheter insertion site in the groin or arm
  • Pain at the catheter insertion site
  • Irregular heartbeats
  • Chest pains during and after the procedure
  • Spasm of the coronary artery
  • Decreased or increased blood pressure

Rare Risks

  • Tearing, puncture, or rupture of the coronary artery
  • Air, pieces of devices, or fragments of clots blocking the coronary or peripheral arteries
  • Complete blockage of the coronary artery, which may require a repeat procedure to reopen the coronary artery
  • Compression of the heart due to accumulation of blood around the heart
  • Re-narrowing of the coronary artery
  • Heart attack
  • Damage to the stent or injury to the coronary artery, requiring emergency heart surgery
  • Bleeding, requiring transfusion or surgery
  • Allergic reaction (may include X-ray dye, cobalt, chromium, nickel, tungsten, everolimus, acrylic, and fluoropolymer)
  • Infection
  • Nerve injury
  • Kidneys fail to function normally
  • Aneurysm (weakening of a portion of the wall of a blood vessel)
  • Shock
  • Stroke
  • Death

Potential adverse events related to taking everolimus daily by mouth (based on long-term everolimus drug studies in organ transplant patients) may include:

  • acne, decreased red or white blood cells, blood clotting abnormalities, diarrhea, water retention in the body, destruction of red blood cells, increased blood cholesterol, increased fat in the blood, increased blood pressure, decreased functioning of sexual organs in men, infections, liver function test abnormality, white blood cell abnormalities, nausea, pain, rash, destruction of the kidney tubules, surgical wound complication, decreased platelet cell count, blood clot in the vein, or vomiting.

Exposure to drug and polymer on the XIENCE V stent is directly related to the number and lengths of the stents implanted. The use of multiple XIENCE V stents will result in you receiving larger amounts of drug and polymer. It should be noted that a kidney transplant patient usually receives a daily dose of the drug everolimus by mouth that is about seven times more than the maximum dose of the drug contained on one XIENCE V stent.

Everolimus, when given by mouth daily to organ transplant patients, may interact with other drugs or substances. Please tell your physician about any medications you are taking.



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.