IMPORTANT SAFETY INFORMATION
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Accunet® Embolic Protection System
The RX Accunet EPS 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 filter basket placement should be between 3.25 mm and 7.0 mm.
The RX Accunet EPS 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 a guiding catheter, sheath, embolic protection system, or stent system, Patients with known hypersensitivity to nickel-titanium, Patients with uncorrected bleeding disorders.
|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.
Refer to the instructions supplied with all interventional devices to be used in conjunction with the RX Accunet EPS for their intended uses, contraindications, and potential complications.
The safety and effectiveness of this device as an embolic protection system have not been established in vasculatures outside the carotid arteries.
The safety and efficacy of the RX Accunet EPS have not been demonstrated with carotid stent systems other than the over-the-wire or RX Acculink Carotid Stent System.
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.
This device is intended for single-use only. Do not reuse. Do not resterilize, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
Do not use the product after the "Use By" date specified on the package.
Maintain the patient’s Activated Clotting Time (ACT) at > 250 seconds throughout RX Accunet EPS usage to prevent thrombus formation on the device.
During positioning, advance the RX Accunet EPS guide wire with filter basket and the delivery sheath as a unit. Advancing the guide wire independent of the delivery sheath may result in premature filter deployment.
Always advance or withdraw the RX Accunet EPS guide wire slowly using fluoroscopy to observe corresponding wire movement in general and tip movement in particular. Never push, auger, retract or torque a guide wire that meets resistance. If the wire tip becomes entrapped within a lesion or a device, such as a deployed stent, do NOT torque the guide wire. Determine the cause of resistance and take necessary remedial action. Torquing or retracting the guide wire against resistance may damage the wire, cause wire tip separation, or cause vessel trauma. Resistance may be felt and / or observed using fluoroscopy by noting any buckling of the guide wire tip.
Maintain continuous flush while removing and reinserting devices on the guide wire. Perform all exchanges slowly to prevent air embolism or trauma to the artery.
Overstretching of the artery may result in rupture and life-threatening bleeding.
When introducing the delivery system, confirm that the wire tip is free within the vessel lumen and is not directed against 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 RX Accunet EPS guide wire and filter basket during catheter device exchanges. Excessive movement of the deployed basket may cause vessel trauma or spasm.
The filter basket must be kept distal to the area to be covered by the stent and proximal to the petrous portion of the carotid artery to avoid excessive forces on the filter basket.
Allow for and maintain adequate distance between the radiopaque proximal bushing marker on the guide wire with filter basket and the stent delivery system or other compatible interventional devices to avoid potential entanglement.
Always keep the open filter basket distal to the deployed stent. Do not attempt to pull an open filter basket through the stent. Do not attempt to capture the filter basket by pulling it into the recovery catheter if the recovery catheter tip is in the stent area. Pulling the filter basket into the stent area may lead to stent-filter basket entanglement and / or basket detachment. If filter basket entanglement or detachment occurs, surgical conversion or collapsing the basket with a second stent should be considered.
Maintain proper guiding catheter / sheath support in the common carotid artery throughout the procedure. If guiding catheter / sheath access cannot be maintained, the case should be discontinued. Failure to maintain proper support of the guiding catheter / sheath can lead to prolapse of the catheter into the aortic arch, resulting in any of the following:
Movement of an open filter through an undilated lesion; or, Filter-stent entanglement, filter basket detachment and / or proximal movement of the stent; or, Filter guide wire breakage.
Do not rotate either recovery catheter more than 90 degrees in either direction since this can result in the guide wire wrapping around the catheter.
Use with fixed (passive) hemostatic valves is not recommended.
If excessive debris is collected in the filter basket such that distal perfusion of dye is significantly reduced or no dye is perfusing past the filter, the RX Accunet EPS may have reached its maximum capacity to contain emboli. Remove and replace the RX Accunet EPS. Otherwise, it may be difficult to completely recover all embolic debris and the potential for thrombus formation may increase.
Discard unused RX Accunet and RX Accunet 2 Recovery Catheters after completing procedure. Failure to discard unused recovery catheters can result in any or all of the following: the use of a device past its “Use By” date; or the use of an incorrectly sized RX Accunet Recovery Catheter, which can cause loss of particulates from the filter basket during recovery, filter-stent entanglement, filter basket detachment and / or proximal movement of stent.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Do not expose the delivery or recovery systems to organic solvents (e.g. alcohol) as structural integrity and / or function of the device may be impaired.
Confirm the compatibility of the RX Accunet EPS with the interventional devices before actual use.
To avoid air entrapment, do not leave the introducer tool in the valve while advancing the delivery system. Advance the delivery system slowly through the guiding catheter / sheath.
Ensure that the torque device is secured tightly to the guide wire to avoid difficulties with deployment. If the torque device is not tightened securely on the guide wire proper deployment may not occur.
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).
Reconfirm the filter basket position prior to deployment of the stent to ensure that there is adequate distance between the radiopaque proximal bushing marker on the guide wire with filter basket and the distal end of the desired stent position. Reposition the filter basket as necessary by gently advancing the guide wire. Under fluoroscopy, observe movement of the filter basket to the desired position.
Observe all guide wire movement in the vessels using fluoroscopic guidance.
Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.
The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.
Do NOT deliver the RX Accunet EPS guide wire with filter basket through any interventional devices other than the RX Accunet EPS delivery sheath.
Removal of the RX Accunet EPS guide wire with filter basket through any interventional devices other than the RX Accunet and RX Accunet 2 Recovery Catheters has not been tested.
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.
If the RX Accunet EPS is desired for intervention in additional vessels, use a new device.
POTENTIAL ADVERSE EVENTS
Based on the literature, and on clinical and commercial experience with the use of embolic protection systems with a carotid stent, the following alphabetical list includes possible adverse events associated with the use of this device:
Allergic reactions to antiplatelet agents / contrast medium, Aneurysm, Angina / coronary ischemia, Arrhythmia, Arterial occlusion / thrombosis at puncture site or remote site, Arteriovenous fistula, Bacteremia or septicemia, Bleeding from anticoagulant or antiplatelet medications, Cerebral edema, Cerebral hemorrhage, Cerebral ischemia / transient ischemic attack (TIA), Congestive heart failure (CHF), Death, Detachment and / or implantation of a component of the system, Emboli, distal (air, tissue, or thrombotic emboli), Emergent or urgent endarterectomy surgery (CEA), Fever, Filter thrombosis / occlusion, Groin hematoma, with or without surgical repair, Hemorrhage, with or without transfusion, Hypotension / hypertension, Infection and pain at insertion site, Ischemia / infarction of tissue / organ, Myocardial infarction (MI), Pain (head, neck), Pseudoaneurysm, femoral, Renal failure / insufficiency, Restenosis of stented / dilated vessel, Seizure, Severe unilateral headache, Stent / filter entanglement / damage, Stroke / cerebrovascular accident (CVA), Total occlusion of carotid artery, Vessel dissection, perforation, or rupture, Vessel spasm or recoil.
Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.