Emboshield^® NAV⁶ Embolic Protection System

INDICATIONS

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. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

CONTRAINDICATIONS

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 tortuousity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and / or RX Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

WARNINGS

Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.

General Warnings

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.

Safety and effectiveness of this device as an embolic protection system has not been established in vasculatures outside of the carotid arteries (coronary, cerebral or peripheral).

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 appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure as suggested in these instructions. Special consideration should be given to those patients with recently active gastritis or peptic ulcer disease.

Specific Warnings

The Emboshield NAV⁶ device can only be used with the BareWire™ Filter Delivery Wire. Use of the device with any guidewire 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.

PRECAUTIONS

Carefully inspect device 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 which is kinked or damaged in any way should not be used.

Confirm the compatibility of the Emboshield NAV⁶ Embolic Protection System with the interventional devices before actual use.

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.

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 segment prior to retrieval, DO NOT RETRIEVE WITHIN THE STENT. Advance the RX Retrieval Catheter so that its tip opposes the proximal portion of the Filtration Element and gently push the Filtration Element distally until it is situated in an unstented portion of vessel. Retrieval can then proceed.

Maintain proper guiding catheter / sheath support in the common carotid artery throughout the procedure.

Ensure that there is adequate 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. The tip of an interventional device should not contact the Filtration Element. Failure to maintain adequate distance could result in Filtration Element engagement with the carotid stent system / interventional device tip and / or Filtration Element entanglement with the deployed stent.

Ensure there is adequate distance between the Filtration Element and the guide wire step. Failure to maintain adequate distance could result in inadvertent Filtration Element movement and Filtration Element engagement with the carotid stent system / interventional device tip and / or Filtration Element entanglement with the deployed stent if the guide catheter or sheath prolapse occurs.

If Filtration Element engagement and / or entanglement or Filter Element detachment occurs, surgical conversion or additional catheter based intervention may be required.

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.

ADVERSE EVENTS

Potential Adverse Events

As reported in the literature, the following adverse events are potentially associated with carotid stents and embolic protection systems:

• Abrupt closure
• Allergic reactions
• Aneurysm
• Angina/Coronary ischemia
• Arteriovenous Fistula
• Bacteremia or septicemia
• Bleeding from anticoagulant or antiplatelet medications
• Bradycardia/arrhythmia
• Cerebral edema
• Cerebral hemorrhage
• Congestive Heart Failure
• Death
• Drug reactions
• Embolism (including air and device)
• Emergent or urgent Endarterectomy
• Fever
• Filter thrombosis/occlusion
• Fluid overload
• Groin hematoma, with or without surgical repair
• Hemorrhage or hematoma
• Hemorrhagic stroke
• Headache
• Hypotension
• Hyperperfusion syndrome
• Hypertension
• Infection/sepsis
• Ischemia/infarction of tissue/organ
• Loss of all of or part of the Filtration Element
• Myocardial Infarction
• Other conduction disturbances
• Pain and tenderness
• Pain, infection, or discomfort at the access site
• Pseudoaneurysm
• Renal failure/insufficiency
• Restenosis of the stented artery
• Seizure
• Stent deformation, collapse, fracture, movement of stent, possibly requiring emergency surgery
• Stent/filter entanglement/damage
• Stroke or other neurological complications
• Thromboembolic episodes
• Thrombophlebitis
• Total occlusion of the artery
• Transient ischemic attacks (TIAs)
• Vascular access complications (e.g. loss of pulse, femoral artery pseudoaneurysm and infection)
• Ventricular fibrillation
• Vessel dissection, rupture, or perforation
• Vessel thrombosis (partial blockage)
• Unstable angina pectoris
• Vascular access complications (e.g. loss of pulse, femoral artery pseudoaneurysm and infection)
• Vasospasm

Any adverse event occurring involving the Emboshield NAV6 Embolic Protection System should be reported immediately to Abbott Vascular, Customer Service: 1-800 227-9902.