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Indication Of Use

The Amplatzer Piccoloâ„¢ 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.

Potential Adverse Events

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, 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.

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Indication for Use:ÌýThe Amplatzerâ„¢ Amuletâ„¢ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

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Contraindications:ÌýThe Amplatzerâ„¢ Amuletâ„¢ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

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·ÌýÌýÌýÌýÌýÌýÌýÌý with the presence of intracardiac thrombus,

·ÌýÌýÌýÌýÌýÌýÌýÌý with active endocarditis or other infections producing bacteremia.

·ÌýÌýÌýÌýÌýÌýÌýÌý where placement of the device would interfere with any intracardiac or intravascular structures.

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Warnings:

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·ÌýÌýÌýÌýÌýÌýÌýÌý If the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.

·ÌýÌýÌýÌýÌýÌýÌýÌý If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.

·ÌýÌýÌýÌýÌýÌýÌýÌý Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.

·ÌýÌýÌýÌýÌýÌýÌýÌý This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.

·ÌýÌýÌýÌýÌýÌýÌýÌý Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.

·ÌýÌýÌýÌýÌýÌýÌýÌý Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.

·ÌýÌýÌýÌýÌýÌýÌýÌý The Amplatzerâ„¢ Amuletâ„¢ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. 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 be instructed to seek medical assistance immediately if they suspect they are experiencing 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.

·ÌýÌýÌýÌýÌýÌýÌýÌý Do not use this device if the sterile package is open or damaged.

·ÌýÌýÌýÌýÌýÌýÌýÌý The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.

·ÌýÌýÌýÌýÌýÌýÌýÌý Use on or before the expiration date that is printed on the product packaging label.

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Precautions:

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·ÌýÌýÌýÌýÌýÌýÌýÌý The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.

·ÌýÌýÌýÌýÌýÌýÌýÌý The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.

·ÌýÌýÌýÌýÌýÌýÌýÌý The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.

·ÌýÌýÌýÌýÌýÌýÌýÌý Ensure that the vasculature is adequate for the sheath size being selected.

·ÌýÌýÌýÌýÌýÌýÌýÌý The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.

·ÌýÌýÌýÌýÌýÌýÌýÌý Use standard interventional cardiovascular catheterization techniques when using Amplatzerâ„¢ products.

·ÌýÌýÌýÌýÌýÌýÌýÌý Use in specific populations

oÌýÌýÌý Pregnancy – Minimize the radiation exposure to the fetus and the mother.

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

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MRI Safety Information:ÌýNon-clinical testing has demonstrated that the Amplatzerâ„¢ Amuletâ„¢ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzerâ„¢Amuletâ„¢ device can be safely scanned in an MR system under the following conditions:

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·ÌýÌýÌýÌýÌýÌýÌýÌý Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)

·ÌýÌýÌýÌýÌýÌýÌýÌý Maximum spatial gradient field of 19 T/m (1900 G/cm)

·ÌýÌýÌýÌýÌýÌýÌýÌý Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

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Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

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In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

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Potential Adverse Events:ÌýPotential adverse events associated with the device or implant procedure include, but are not limited to, the following:

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·ÌýÌýÌýÌýÌýÌýÌýÌý Air embolism

·ÌýÌýÌýÌýÌýÌýÌýÌý Airway trauma

·ÌýÌýÌýÌýÌýÌýÌýÌý Allergic reaction

·ÌýÌýÌýÌýÌýÌýÌýÌý Anemia

·ÌýÌýÌýÌýÌýÌýÌýÌý Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)

·ÌýÌýÌýÌýÌýÌýÌýÌý Arrhythmia

·ÌýÌýÌýÌýÌýÌýÌýÌý Atrial septal defect

·ÌýÌýÌýÌýÌýÌýÌýÌý Bleeding

·ÌýÌýÌýÌýÌýÌýÌýÌý Cardiac arrest

·ÌýÌýÌýÌýÌýÌýÌýÌý Cardiac tamponade

·ÌýÌýÌýÌýÌýÌýÌýÌý Chest pain/discomfort

·ÌýÌýÌýÌýÌýÌýÌýÌý Congestive heart failure

·ÌýÌýÌýÌýÌýÌýÌýÌý Death

·ÌýÌýÌýÌýÌýÌýÌýÌý Device embolization

·ÌýÌýÌýÌýÌýÌýÌýÌý Device erosion

·ÌýÌýÌýÌýÌýÌýÌýÌý Device malfunction

·ÌýÌýÌýÌýÌýÌýÌýÌý Device malposition

·ÌýÌýÌýÌýÌýÌýÌýÌý Device migration

·ÌýÌýÌýÌýÌýÌýÌýÌý Device-related thrombus

·ÌýÌýÌýÌýÌýÌýÌýÌý Fever

·ÌýÌýÌýÌýÌýÌýÌýÌý Hematuria

·ÌýÌýÌýÌýÌýÌýÌýÌý Hypertension/hypotension

·ÌýÌýÌýÌýÌýÌýÌýÌý Infection

·ÌýÌýÌýÌýÌýÌýÌýÌý Multi-organ failure

·ÌýÌýÌýÌýÌýÌýÌýÌý Myocardial infarction

·ÌýÌýÌýÌýÌýÌýÌýÌý Perforation

·ÌýÌýÌýÌýÌýÌýÌýÌý Pericardial effusion

·ÌýÌýÌýÌýÌýÌýÌýÌý Pleural effusion

·ÌýÌýÌýÌýÌýÌýÌýÌý Renal failure/dysfunction

·ÌýÌýÌýÌýÌýÌýÌýÌý Respiratory failure

·ÌýÌýÌýÌýÌýÌýÌýÌý Seizure

·ÌýÌýÌýÌýÌýÌýÌýÌý Significant residual flow

·ÌýÌýÌýÌýÌýÌýÌýÌý Stroke

·ÌýÌýÌýÌýÌýÌýÌýÌý Thrombocytopenia

·ÌýÌýÌýÌýÌýÌýÌýÌý Thromboembolism: peripheral and pulmonary

·ÌýÌýÌýÌýÌýÌýÌýÌý Thrombus formation

·ÌýÌýÌýÌýÌýÌýÌýÌý Transient ischemic attack

·ÌýÌýÌýÌýÌýÌýÌýÌý Valvular regurgitation/insufficiency

·ÌýÌýÌýÌýÌýÌýÌýÌý Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)

·ÌýÌýÌýÌýÌýÌýÌýÌý Vessel trauma/injury

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INDICATION FOR USE

The AMPLATZERâ„¢ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

CONTRAINDICATIONS

The AMPLATZERâ„¢ Septal Occluder is contraindicated for the following:

• Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
• Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

WARNINGS

• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
• Use on or before the expiration date noted on the product packaging.
• This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the AMPLATZERâ„¢ Septal Occluder from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
• Implantation of this device may not supplant the need for Coumadinâ„¢ in patients with ASD and paradoxical emboli.
• The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
• Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do not inflate the balloon beyond the cessation of the shunt (such as, stop-flow). DO NOT OVERINFLATE.
• Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at increased risk of erosion.
• Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.

PRECAUTIONS

• The use of this device has not been studied in patients with patent foramen ovale.
• Use standard interventional cardiac catheterization techniques to place this device.
• Placement of the AMPLATZERâ„¢ Septal Occluder may impact future cardiac interventions, for example transeptal puncture and mitral valve repair.
• This device 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. 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 be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

MR Conditional to 3.0 Tesla

Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla. In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

POTENTIAL ADVERSE EVENTS

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

Air embolus; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Cardiac tamponade; Death; Embolization; Fever; Hypertension/ hypotension; Infection including endocarditis; Need for surgery; Pericardial effusion; Perforation of vessel or myocardium; Pseudoaneurysm including blood loss requiring transfusion; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation.