Amplatzer™ Septal Occluders

Rx Only

Important Safety Information

AMPLATZER™ CRIBRIFORM MULTIFENESTRATED SEPTAL OCCLUDER

Indication for Use

The Amplatzer™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal defects (ASD).

Patients indicated for ASD closure have echocardiographic evidence of fenestrated 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 right ventricular enlargement).

Contraindications

The Amplatzer™ Cribriform Occluder is contraindicated for the following: Treatment of patients with patent foramen ovale (PFO) defects. This device has not been studied in patients with PFO defects. Patients known to have extensive congenital cardiac anomaly, which can only be adequately repaired by way of cardiac surgery; Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement; Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months; Patients known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi); Patients whose size (such as, too small for transesophageal echocardiography (TEE) probe, catheter size, vasculature size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization; Any patient where the radius of the device is greater than the distance from the central defect to the aortic root or superior vena cava.

Adverse Events

Observed Adverse Events – Tissue Erosion/Perforation: The reported incidence of tissue erosion/perforation is approximately 1 in 1,000 patients treated with the Amplatzer™ Septal Occluder. Tissue erosion, while rare, has led to cardiac tamponade and death. Tissue erosion/perforation refers to the erosion or abrasion of the tissue of the atrium primarily in the area of the roof of the atrium near the aorta.

Potential Adverse Events: Potential adverse events that 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; Brachial plexus injury; Cardiac perforation; Death, Device collapse due to structural failure; Device embolization; Device removal (due to embolization or misplacement); Erosion; Fever; Headache/migraines; Hematoma/pseudoaneurysm including blood loss requiring transfusion; Hypertension; hypotension; Infection including endocarditis; Infectious endocarditis; Pericardial effusion; Perforation of vessel or myocardium; Phrenic nerve injury; Stroke/transient ischemic attack; Thrombus formation on the device surface with the risk of subsequent embolization; Valvular regurgitation; Vascular access site complications.