FilterWire EZ™ Embolic Protection System for SVG's

Prescriptive Information

Indications

The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of the filter loop placement should be between 2.25mm and 5.5mm for coronary saphenous vein bypass graft procedures and between 3.5mm and 5.5mm for carotid procedures.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.

Contraindications

• Patients with severe allergy to heparin.
• Patients with bleeding diathesis or other disorders which limit the use of anticoagulant therapy.

Warnings

• Only physicians thoroughly trained in percutaneous, intravascular techniques and procedures should use the FilterWire EZ System.
• The safety and effectiveness of coronary drug-eluting stents (DES) when used with embolic protection devices has not been established.
• The safety and effectiveness of the FilterWire EZ System has not been demonstrated with carotid stents other than the NexStent® Carotid Stent and Delivery System (NexStent Carotid Stent).
• The diameter of the vessel at the site of the filter loop placement should be between 2.25mm and 5.5mm for coronary saphenous vein bypass graft procedures and between 3.5mm and 5.5mm for carotid procedures.
• Avoid using power injection in the cerebral circulation.
• Filter safety and effectiveness has not been tested with power injection.
• Failure to follow recommended device preparation and delivery instructions may result in air embolism.
• Introduce and advance devices slowly to prevent air embolism or trauma to the vasculature.
• Do not attempt to move the protection wire without observing the resultant tip response.
• All distal wire tips have the potential to cause vessel injury. Confirm that the wire tip is free within the vessel.
• Do not use excessive force when attempting to cross the lesion with the FilterWire EZ System.
• Observe all protection wire movement in the vessel under fluoroscopic imaging.
• Always keep the open filter loop distal to a deployed stent. Pulling the filter loop into the stent area may lead to entanglement with the stent and possible filter loop detachment.
• Ensure that the protection wire is stabilized throughout the procedure. Failure to stabilize the protection wire could lead to inadvertent movement of the filter resulting in protection wire entanglement and/or delay in the procedure.
• Do not pull excessively on the protection wire or the EZ Retrieval Sheath to avoid filter membrane tears, filter loop detachment or other protection wire damage.

Potential Adverse Effects

Possible adverse effects include, but are not limited to, the following:

• Angina
• Bleeding complications
• Bradycardia or arrhythmias, including ventricular fibrillation or tachycardia
• Congestive heart failure
• Damage to or dislocation of the implanted stent(s)
• Death
• Detachment and/or implantation of a component of the system
• Drug reaction, allergic reaction to contrast media, medications or device materials
• Emergent surgery
• Embolization of air, tissue, thrombus or other embolic debris
• End organ ischemia, vessel thrombosis or spasm
• Hypotension/hypertension
• Infection (local or systemic)
• Myocardial infarction
• No-reflow resulting from reduced blood flow through the FilterWire EZ™ System filter
• Puncture site complications (i.e., vessel occlusion, hemorrhage, hematoma, pseudoaneurysm or arteriovenous fistula)
• Renal insufficiency, kidney failure, hematuria
• Stroke/Cerebrovascular accident (CVA), transient ischemic attack (TIA) or seizure
• Vessel damage, dissection, occlusion, aneurysm, perforation, rupture or injury

Cautions

Federal Law (USA) restricts this device to sale by or on the order of a physician.

Trademark

FilterWire EZ and NexStent are trademarks of Boston Scientific Corporation or its affiliates.