FilterWire EZ™ Embolic Protection System

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Boston Scientific FilterWire EZ Embolic Protection System is indicated for use as a guidewire 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 filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

The safety and effectiveness of this device as an embolic protection system have 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 that limit the use of anticoagulant therapy

WARNINGS

• The safety and effectiveness of coronary drug-eluting stents (DES) when used with embolic protection devices have not been established.
• The safety and effectiveness of the FilterWire EZ Embolic Protection System have not been demonstrated with carotid stents other than the Carotid WALLSTENT Monorail Endoprosthesis and Delivery System (Carotid WALLSTENT Endoprosthesis) and the NexStent Carotid Stent and Monorail Delivery System (NexStent Carotid Stent).
• The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure to minimize the risk of embolism and thrombosis.
• Failure to follow recommended device preparation and delivery instructions may result in embolism or other adverse event.
• Avoid using power injection in the cerebral circulation.
• Filter safety and effectiveness has not been tested with power injection.

PRECAUTIONS

• For SVG applications, prior to use, heparinize the patient to achieve an Activated Clotting Time (ACT) of > 300 seconds (> 200 seconds if using GP IIb/IIIa inhibitors) or in absence of ACT measurement, administer an appropriate weight-based bolus of heparin (approximately 125 units/kg).
• For carotid procedures, administer heparin and monitor ACT to maintain > 275 seconds throughout the procedure.
• Venous access should be available in order to manage bradycardia and/or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.
• Confirm angiographically that the vessel diameter is appropriate for treatment with the FilterWire EZ Embolic Protection System and ensure that the correct device size is selected. The reference vessel diameter at the filter loop deployment site must be at least 2.25 mm but no greater than 3.5 mm for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) and at least 3.5 mm but no greater than 5.5 mm for the FilterWire EZ Embolic Protection System (3.5 mm - 5.5 mm).
• Confirm angiographically that there is sufficient vessel length to place the filter to allow for and maintain adequate distance between the protection wire’s catheter stop and the stent delivery system or other compatible interventional devices (see Table 3 and Figure 2).
• Use of a guide catheter with a rotating hemostasis valve is recommended when performing a procedure with the FilterWire EZ Embolic Protection System.
• Use caution when advancing or retracting the FilterWire EZ Embolic Protection System through a deployed stent as this may cause stent/filter entanglement or stent dislocation.

ADVERSE EVENTS
Possible adverse events associated with the use of the FilterWire EZ Embolic Protection System, including the EZ Bent Tip Retrieval Sheath, and application procedure include, but are not limited to, the following:

• Allergic reactions (drug, contrast, device or other)
• Angina
• Arrhythmias (e.g. bradycardia, ventricular fibrillation or others)
• Arteriovenous fistula
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA), stroke, transient ischemic attack (TIA) or seizure
• Congestive heart failure
• Damage to or dislocation of the implanted stent(s)
• Death
• Detachment and/or implantation of a component of the system
• Embolization (air, plaque, thrombus, device or other)
• Headache
• Hematoma
• Hypotension/hypertension
• Infection/sepsis
• Ischemia/infarction
• Myocardial infarction
• Need for urgent intervention or surgery
• Pain
• Renal insufficiency or failure
• Thrombus/thrombosis
• Vessel trauma (perforation, rupture, dissection, pseudoaneurysm)
• Vessel occlusion, including no reflow or reduced blood flow through FilterWire EZ Embolic Protection System
• Vessel spasm