IMPORTANT SAFETY INFORMATION
Emboshield NAV6™ Embolic Protection System
The Emboshield NAV6™ 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 carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV6™ Embolic Protection System is contraindicated for use in
- Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
- Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, Embolic Protection System.
- Patients with a known allergy or hypersensitivity to device materials (Nitinol, Nickel, Titanium) or contrast medium, who cannot be adequately premedicated.
- Patients with uncorrected bleeding disorders.
- Lesions in the ostium of the common carotid artery.
- Inability to cross the lesion with the BareWire™ Filter Delivery Wire.
- Diffusely diseased vessels where there is no disease-free section in which to deploy the Filtration Element
- Insufficient straight section of vessel distal to the lesion to permit Filtration Element deployment.
Use of the device should be restricted to physicians trained to the specifics of the device and to the Instructions for Use. Operators must be knowledgeable of the current medical literature and familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid and lower extremity interventional procedures.
Refer to instructions supplied with all interventional devices to be used with the Emboshield NAV6™ Embolic Protection System for their intended uses, contraindications, and potential complications.
The Emboshield NAV6™ System is supplied sterile. Do not use if the package has been opened or is damaged. Carefully inspect the system components prior to use to verify that they have not been damaged and that the size, shape and condition are suitable for the procedure for which they are to be used. A device or access device that is kinked or damaged in any way should not be used.
Safety and effectiveness of this device as an embolic protection system has not been established in the coronary or cerebral vasculature.
The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with carotid stent systems other than the Xact™ or Acculink™ Carotid Stent Systems.
The safety and efficacy of the Emboshield NAV6™ Embolic Protection System has not been demonstrated with atherectomy devices other than Turbo-Elite‡ Laser Atherectomy Catheter, Jetstream‡ Single Cutter (SC) Atherectomy Catheter, Jetstream‡ eXpandable Cutter (XC) Atherectomy Catheter and TurboHawk‡ Peripheral Plaque Excision System.
The Emboshield NAV6™ device can only be used with the BareWire™ Filter Delivery Wire. Use of the device with any guide wire other than the BareWire™ Filter Delivery Wire will lead to loss of the Filtration Element during the procedure or an inability to retrieve the Filtration Element.
To reduce the potential for the liberation of emboli during lesion crossing, the device should be carefully manipulated and not advanced against resistance.
If the Filtration Element moves into the stented vessel segment prior to retrieval, DO NOT RETRIEVE. Use the Retrieval Catheter to gently maneuver the Filtration Element distally until it is situated in an unstented portion of vessel. Retrieval should then proceed.
Maintain proper guiding catheter / sheath support throughout the procedure. Ensure that there is enough distance between the proximal tip of the Filtration Element and the most distal tip of any interventional device to be introduced over the Filter Delivery Wire to avoid engagement. The tip of a balloon catheter or a stent delivery system or an atherectomy device should not contact the Filtration Element. Failure to maintain adequate distance could result in inadvertent Filtration Element movement and Stent Delivery System tip / Filtration Element entanglement and / or Filtration Element /Stent entanglement if guide catheter or sheath prolapse occurs.
Precautions to prevent or reduce clotting should be taken when any interventional device is used. Flush or rinse all devices entering the vascular system with heparinized normal saline or alternative anticoagulant, prior to use.
The Emboshield NAV6™ Embolic Protection System must be used with a guiding catheter or introducer sheath to maintain adequate support for the BareWire™ Filter Delivery Wire throughout the procedure.
Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or place of a temporary pacemaker, if needed.
Removal of the BareWire™ Filter Delivery Wire with the Emboshield NAV6™ Filtration Element through any interventional devices other than the Emboshield NAV6™ RX Retrieval Catheter has not been tested.
The minimum expanded stent internal diameter required for retrieval of a large embolic load is 2.5 mm.
As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:
- Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, stent material (Nitinol, Nickel, Titanium) and drug reactions to anticoagulation, or antiplatelet drugs
- Vascular access complications which may require transfusion or vessel repair, including:
- Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
- Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture, and laceration
- Embolism (air, tissue, plaque, thrombotic material or device)
- Target artery complications which may require additional intervention, including:
- Total occlusion or abrupt closure
- Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation/rupture
- Embolism (air, tissue, plaque, thrombotic material or device)
- Stenosis or restenosis
- Artery, stent, or filter thrombosis / occlusion thrombosis
- Vessel spasm
- Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
- Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction, and unstable or stable angina pectoris)
- Stroke/Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
- System organ failures:
- Cardio Pulmonary failure
- Renal failure / insufficiency
- Blood cell disorders including heparin induce thrombocytopenia and other coagulopathy
- Peripheral nerve injury
- Other ischemic conditions/infarct
- Infection - local and systemic (including postprocedural)
- Nausea and vomiting
- Chest pain
- Edema/Cerebral edema and fluid overload
- Pain, including headache
- Hyperperfusion syndrome
- Other neurologic and systemic complications
- Cerebral hemorrhage
Any adverse event occurring involving the Emboshield NAV6™ Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.