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Indications, Safety & Warnings

Structural Heart Therapy

Rx Only

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.

Indication: The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

Contradictions: Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained. Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size. Patients with anatomy in which the AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins. Patients with other source-left shunts, including an atrial septal defect and/or fenestrated septum. Patients with active endocarditis or other untreated infections.

Potential Adverse Effects: Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Headache/migraine, Allergic dye reaction, Hypertension/hypotension, Allergic drug reaction, Myocardial infarction, Allergic metal reaction ( nickel, titanium, chromium, iron, manganese, molybdenum). Anesthesia reactions, Pacemaker placement secondary to PFO device closure, Apnea, Palpitations, Arrhythmia, Pericardial effusion, Bacterial endocarditis, Pericardial tamponade, Bleeding, Pericarditis, Brachial plexus injury, Peripheral embolism, Cardiac perforation, Pleural effusion, Cardiac tamponade, Pulmonary embolism, Cardiac thrombus, Reintervention for residual shunt/device removal, Chest pain, Sepsis, Device embolization, Stroke, Device erosion, Transient ischemic attack, Deep vein thrombosis, Thrombus, Death, Valvular regurgitation, Endocarditis, Vascular access site injury, Esophagus injury, Vessel perforation and Fever. Clinician's manual must be reviewed for detailed disclosure.