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 FOR USE:

The AMPLATZER™ 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).

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 Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.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 AMPLATZER™ 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 Coumadin™ 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.

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