Emboshield NAV^6™ 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 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.
 

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 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.

Warnings

General Warning

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.

This device is designed and intended for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and / or delivery system and / or lead to device failure, which may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and / or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device and / or delivery system may lead to injury, illness or death of the patient.

Store in a cool, dark, dry area. Do not use the product after the Use by date specified on the label.
Overstretching of the artery may result in rupture and life-threatening bleeding.

Appropriate antiplatelet, anticoagulant and, if necessary, vasodilator therapy must be used during the procedure. Anticoagulant therapy sufficient to maintain an Activated Clotting Time of at least 250 seconds for the duration of the procedure is recommended.

Adequate guide catheter or sheath support is required for the introduction of the RX Delivery Catheter, RX Retrieval Catheter, and all interventional devices to be used during the procedure.

Maintain a snug seal between the device and the hemostasis valve during catheter insertion. Failure to observe this may result in air being drawn into the access device through the hemostasis valve. Device insertion should be performed slowly to minimize the risk of air entrainment. It is therefore recommended that flushing of contrast media (or other fluids) is performed before or after insertion of the catheter, but not while the catheter is within the access device.

Do not advance any component of the Emboshield NAV⁶ ™ Embolic Protection System against significant resistance. The cause of any resistance should be determined via fluoroscopy and remedial action taken.

Torquing the BareWire™ Filter Delivery Wire against resistance may cause BareWire™ Filter Delivery Wire damage and / or BareWire™ Filter Delivery Wire tip separation.

Perform all exchanges slowly to prevent air embolism or trauma to the artery.

The RX Delivery Catheter should not be pulled back quickly in the event that resistance is felt during catheter advancement. Rapid withdrawal of the RX Delivery Catheter in the presence of resistance may result in premature deployment of the Filtration Element.

In the event of complications, surgical intervention may be required.

A high pressure contrast injection may cause Filtration Element movement in the vessel.

Do not attempt to move the Filtration Element after deployment and prior to the start of retrieval. Do not torque the RX Delivery and RX Retrieval Catheters.

Allow and maintain adequate distance between the Emboshield NAV⁶ ™ Filtration Element and other interventional devices (including carotid stent systems and balloons) to avoid engagement.

When introducing the delivery system, confirm that the wire tip is free within the vessel lumen and is not directed into the vessel wall. Failure to do so may result in vessel trauma. Use the radiopaque marker on the interventional device to confirm position.

Avoid excessive movement of the filter basket during catheter device exchanges. Excessive movement of the deployed basket may cause vessel trauma or spasm.

After use, this device, its accessories and packaging should be appropriately classified for disposal (e.g., biohazard, sharps, non-hazardous waste, etc.) and carefully disposed of in compliance with facility procedures and applicable laws and regulations.

The following vessel anatomy specifications preclude the use of the stent system or appropriate positioning of the embolic protection system:

• Hemoglobin (Hgb) < 8 gm/dl (unless on dialysis), platelet count < 50,000, INR > 1.5 (irreversible), or heparin-associated thrombocytopenia.
• Evidence of a stroke within the previous 30 days.
• History of ipsilateral stroke with fluctuating neurologic symptoms within 1 year.
• Patients with total occlusion of the target vessel.
• Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
• Any condition that precluded proper angiographic assessment or made percutaneous arterial access unsafe (e.g., morbid obesity, sustained systolic blood pressure > 180 mmHg).
• Known cardiac sources of emboli.
• Patients with highly calcified lesions resistant to PTA.
• Atherosclerotic disease involving adjoining vessels precluding safe placement of the guiding catheter or sheath.
• The safety and effectiveness of concurrent treatment of lesions in patients with bilateral carotid artery disease have not been established.

Caution should be used if pre-dilating the lesion without embolic protection as this may increase the risk of an adverse outcome.
The BareWire™ Filter Delivery Wire should be kept moistened throughout the procedure.
The Filtration Element can only be positioned proximal to the radiopaque distal section of the Filter Delivery Wire.
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.

In patients requiring the use of antacids and / or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g., aspirin) may be adversely affected.

The minimum guide catheter or sheath internal diameter is printed on the package label. Do not use a smaller guide catheter or sheath than indicated.

For proper positioning of the filter basket, the vessel distal to the lesion should have an absence of excessive tortuosity and be of adequate length (approximately 4 cm distal to the lesion and proximal to the petrous portion of the vessel).

Do not pull back on the BareWire™ Filter Delivery Wire during advancement.

The Emboshield NAV⁶ ™ Embolic Protection System is not to be deployed with an access device that uses an integrated leaflet type valve.

Precautions

The device must only be flushed using the 3-ml syringe and flushing tip provided. Use with fixed (passive) hemostatic valves is not recommended.

For best device performance, the guide wire exit notch should remain within the guiding catheter or sheath.

The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.

Care must be used when removing the filter basket through a newly deployed stent to maintain filter basket integrity and to avoid disrupting the stent geometry.

To optimize system performance, it is imperative that careful attention is paid to the preparation of the system using the preparation techniques specified in the Instructions For Use. The size of the Filtration Element should be selected to match the diameter of the vessel at the intended site of deployment.

The clinician should take into consideration the slight increase in vessel diameter that may occur after treatment of the lesion.

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.

Do not torque the RX Delivery and RX Retrieval Catheters.

The maintenance of blood flow through the device should be observed throughout the procedure by the use of contrast injection.

If excessive debris is collected in the Filtration Element such that distal profusion of dye is significantly reduced or no dye is perfusing past the filter, the Emboshield NAV⁶ ™ device may have reached its maximum capacity to contain emboli. Remove and replace the

Emboshield NAV⁶ ™ device. Otherwise, it may be difficult to completely recover all embolic debris and the potential for thrombus formation may increase.

Do not attempt to move the Filtration Element after deployment and prior to the start of retrieval.

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.

During the insertion of Rapid Exchange catheters through guide catheters or sheaths, careful handling is required to ensure that air is not drawn into the access device. It is therefore recommended that flushing of contrast media (or other fluids) is performed before or after insertion of the catheter, but not while the catheter is within the access device.

Deployment of the Filtration Element, the subsequent deployment of complementary interventional devices over the BareWire™ Filter Delivery Wire, and the retrieval of the Filtration Element should only be performed under fluoroscopic observation.

Potential Adverse Events

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)
  • Thrombophlebitis
• 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
• Hypotension/hypertension
• Peripheral nerve injury
• Other ischemic conditions/infarct
• Infection - local and systemic (including postproceural)
• Chest pain
• Edema/Cerebral edema and fluid overload
• Fever
• Pain, including headache
• Hyperperfusion syndrome
• Other neurologic and systemic complications
• Cerebral hemorrhage
• Death

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