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 MULTI-LINK 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.
• Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications 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 and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.
• Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:
• Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, 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 < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, 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, multivessel disease, and in-stent restenosis.
• Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.
• 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 and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.
• Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.
• The XIENCE Family of stents 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 percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

• Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, 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, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

• Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting
• Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time

If your doctor recommends an ablation procedure to treat your arrhythmia, your medical team will ablate or carefully create scar tissue in your heart to block the abnormal electrical pathways. Catheter ablation is one type of cardiac ablation.

CATHETER ABLATION 

Typically, during catheter ablation, your doctor threads several catheters—special long, flexible tubes with wires—through a blood vessel in your groin and up into your heart. Your doctor uses some of these catheters to study your arrhythmia, and others to carefully scar abnormal tissue as treatment for your arrhythmia.

CATHETER ABLATION RISKS

• Because a cardiac ablation procedure requires your doctor to insert catheters into your body, there are risks, including:
• Swelling or bruising where the catheters were inserted
• Infection, damage to the heart or blood vessels
• Damage to your heart’s electrical system; if this happens, your doctor may need to implant a pacemaker
• Side effects from the anesthesia, which can vary and depend on a number of health factors

Never forget that your doctor is your best source of information about risks. Be sure to consult with your doctor about risks before you undergo your procedure, and discuss any concerns you might have afterwards.

THE CATHETER ABLATION PROCEDURE

You are likely to be deeply sedated during the procedure. The catheter ablation typically follows these steps:

1. Your doctor makes a small cut, usually near your groin, and finds a suitable blood vessel (typically a vein, but sometimes an artery).
2. Puncturing the blood vessel (typically a vein, but sometimes an artery) with a needle, your doctor then inserts a diagnostic or ablation catheter, or both.
3. Your doctor gently guides the diagnostic catheters toward your heart. He or she follows the catheter’s progress with a kind of X-ray machine called a fluoroscope that allows your doctor to visualize the catheters.
4. Using the diagnostic catheter to measure your heart’s electrical activity, your doctor identifies abnormalities and possibly stimulates contractions.
5. Your doctor then uses the ablation catheter to deliver energy to either burn or freeze the targeted areas, creating scar tissue.
6. Your doctor removes the catheters and bandages the insertion site.

IMMEDIATE RECOVERY AFTER CATHETER ABLATION

After your procedure, your medical team will move you to a recovery area. Depending on your condition, you may be able to go home the same day of your procedure, or you may need to stay in the hospital for a longer period. Your doctor may prescribe blood-thinning or other medication for a period of time after your procedure. Always remember that your doctor is your best source of information about what to expect during your immediate recovery process.

PULMONARY ARTERY (PA) CARDIOMEMS PRESSURE SENSOR

INTERFERENCE

As with any procedure, there are potential risks involved with having a PA sensor implanted, including electromagnetic interference. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the procedure, including: arrhythmias, bleeding, death, device embolization, hematoma (blood clot), infection, myocardial infarction (heart attack), stroke, transient ischemic attack (often called a ministroke) and thrombus (blood clot).

Your PA sensor has built-in features that protect it from interference produced by most electrical equipment. Most of the things you handle or work around on a daily basis are not going to affect your sensor. Any type of electromagnetic interference such as theft detection systems and airport security systems could make it difficult to take sensor measurements. It would be highly unlikely that you would be taking measurements at the same time that these devices are in your vicinity. Electric blankets or waterbeds could be the possible exception because they are found in the home and could be in the area when measurements are taken. If they are causing interference, you may want to move the electric blanket out of the room or in the case of a waterbed take the measurement in another room.

Consult your doctor about all possible benefits and risks.

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

A CRT-P monitors the heart’s rate and rhythm and provides electrical stimulation when the heart does not beat or beats too slowly. The CRT-P is designed for patients who have an abnormally slow heart rate, and for heart failure patients and patients whose hearts are in need of resynchronization.

As with any surgery, there are potential risks involved with having a CRT-P implanted. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the implant surgery, including bleeding, infection, or lead dislodgement. Lead or device problems also can occur following surgery. Generally, risks depend on age, general health, your specific medical condition and heart function. After receiving a CRT-P, items with strong magnetic fields, including MRI machines, should be avoided. Some appliances and tools also can affect the device.

This device is available by prescription only and is not right for everyone. Individual results may vary. Consult your doctor about all possible benefits and risks.

CARDIAC RESYNCHRONIZATION THERAPY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (CRT-D)

CRT-Ds treat dangerously fast rhythm disorders called ventricular tachycardia and ventricular fibrillation in the lower chambers of the heart, and are for heart failure patients and patients whose hearts are in need of resynchronization. For a HF patient or patient whose heart requires resynchronization, the CRT-D sends a shock to the heart muscle to interrupt the rhythm disorder and allow the heart to resume its normal rhythm.

As with any surgery, there are potential risks involved with having a CRT-D implanted. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the implant surgery, including bleeding, infection, or lead dislodgement. Lead or device problems also can occur following surgery. Generally, risks depend on age, general health, your specific medical condition and heart function. After receiving a CRT-D, items with strong magnetic fields, including MRI machines, should be avoided.

This device is available by prescription only and is not right for everyone. Individual results may vary. Consult your doctor about all possible benefits and risks.

LEFT VENTRICULAR ASSIST DEVICE (LVAD)

Complications of surgery to receive an LVAD are similar to the potential complications of any open heart surgery procedure. You will be asked to sign a surgical consent form prior to the operation, as well as a consent form for blood transfusions. Your surgeon will discuss potential risks and benefits with you prior to the procedure.

Possible serious adverse events include death, bleeding (during surgery or after surgery), cardiac arrhythmia (irregular heartbeat), local infection, respiratory failure, device malfunction, sepsis (serious infection), right heart failure, driveline or pocket infection, renal failure (inability of the kidneys to remove waste from the blood), stroke, neurologic dysfunction (problems affecting the brain or nervous system), psychiatric episode, thromboembolic event, peripheral (blood clots), hemolysis (breakdown of red blood cells), hepatic dysfunction (liver problems), device thrombosis (formation of a blood clot inside the device) and myocardial infarction (heart attack).

Individual experiences, symptoms, situations, and circumstances may vary. Please consult your physician or qualified healthcare provider regarding your condition and appropriate medical treatment.

PRODUCT ADVISORIES

Abbott Cardiovascular is committed to presenting information with accuracy and integrity. Occasionally we discover product issues that we feel are important to share with patients. These notices will be published here.

BRIEF SUMMARY:

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

INDICATIONS AND USAGE:

The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

CONTRAINDICATIONS:

The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

POTENTIALS ADVERSE EVENTS:

Potential adverse events associated with the implantation procedure include, but are not limited to, the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

INDICATIONS AND USAGE 

The AMPLATZER Piccolo^TM Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA). 

CONTRAINDICATIONS

• Weight < 700 grams at time of the procedure
• Age < 3 days at time of procedure
• Coarctation of the aorta
• Left pulmonary artery stenosis
• Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
• Intracardiac thrombus that may interfere with the implant procedure
• Active infection requiring treatment at the time of implant
• Patients with a PDA length smaller than 3 mm
• Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

WARNINGS 

• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Do not use the device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• Patients who are allergic to nickel can have an allergic reaction to this device.
• Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.
• Accurate measurements of the ductus are crucial for correct occluder size selection.
• Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.
• Remove embolized devices. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter

PRECAUTIONS 

• This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.
• Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.
• The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury.
• The AMPLATZER Piccolo^TM Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
• Use in specific populations

Pregnancy — Minimize radiation exposure to the fetus and the mother.

Nursing mothers — There has been no quantitative assessment for the presence of leachables in breast milk.

• Store in a dry place.
• Do not use contrast power injection with delivery catheter

POTENTIAL ADVERSE EVENTS 

Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to: 

• Air embolus
• Allergic dye reaction
• Allergic drug reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Bacterial endocarditis
• Bleeding
• Cardiac perforation
• Cardiac tamponade
• Chest pain
• Device embolization
• Device erosion
• Death
• Fever
• Headache/migraine
• Hemolysis
• Hematoma
• Hypertension
• Hypotension
• Infection
• Myocardial infarction
• Palpitations
• Partial obstruction of aorta
• Partial obstruction of pulmonary artery Pericardial effusion
• Pericarditis
• Peripheral embolism
• Pleural effusion
• Pulmonary embolism
• Re-intervention for device removal
• Respiratory distress
• Stroke
• Thrombus
• Transient ischemic attack
• Valvular regurgitation
• Vascular access site injury
• Vascular occlusion
• Vessel perforation