Carotid WALLSTENT™ Monorail™ Endoprosthesis
Indications, Safety, and Warnings
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.
The Carotid WALLSTENT Monorail Endoprosthesis (Carotid WALLSTENT Endoprosthesis), used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below:
- Patients with neurological symptoms and ≥50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, AND
- Patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
The Carotid WALLSTENT Endoprosthesis 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 guide catheter, sheath, embolic protection system or stent system
- Patients with uncorrected bleeding disorders
- Lesions in the ostium of the common carotid artery
- Refer to the Directions for Use supplied with any interventional devices to be used in conjunction with the Carotid WALLSTENT Endoprosthesis for their intended uses, contraindications, and potential complications.
- The safety and efficacy of the Carotid WALLSTENT Endoprosthesis have not been demonstrated with embolic protection devices other than the FilterWire EZ™ System.
- Risk of distal embolization may be higher if the Carotid WALLSTENT Endoprosthesis cannot be used in conjunction with an embolic protection system during the carotid stenting procedure.
- The long-term performance of the Carotid WALLSTENT Endoprosthesis has not been established.
- Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
- In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents such as aspirin may be adversely affected.
- The implantation of the Carotid WALLSTENT Endoprosthesis should be performed only under fluoroscopic observation with radiographic equipment providing high-resolution images.
- Never advance the Carotid WALLSTENT Endoprosthesis without the guidewire extending from the tip.
- Do not advance the Carotid WALLSTENT Endoprosthesis against significant resistance.
- The Carotid WALLSTENT Endoprosthesis should be oversized in relation to the artery diameter by 1 mm to 2 mm to prevent migration.
- Do not release the Carotid WALLSTENT Endoprosthesis if unusual force is required; in such a situation use another device.
- Never advance a partially deployed Carotid WALLSTENT Endoprosthesis distally.
- Reconstrainment and repositioning of the Carotid WALLSTENT Endoprosthesis should be strictly avoided when the partially deployed Carotid WALLSTENT Endoprosthesis is already in contact with the plaque of the stenosis.
- Use of this device in patients with hypersensitivity to cobalt, chromium, iron, nickel, or molybdenum may provoke an allergic reaction.
- Avoid using power injection in the cerebral circulation.
- Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent and may cause acute closure of the vessel, requiring additional intervention (carotid endarterectomy, further dilatation, or placement of additional stents).
- The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
- In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
- Overstretching of the artery may result in rupture and lifethreatening bleeding.
- Balloon angioplasty of the carotid bifurcation may initiate transient hemodynamic instability consisting of bradycardia or hypotension. Appropriate pharmacologic therapy must be immediately available.
- Do not hold the sheath or stent during stylus removal.
- The Carotid WALLSTENT Endoprosthesis is not compatible with any guidewire larger than 0.014 in (0.36 mm).
- The Carotid WALLSTENT Endoprosthesis must be used with a guiding catheter or guiding sheath to maintain adequate support of the 0.014 in (0.36 mm) guidewire throughout the procedure.
- For best device performance, the guidewire exit notch should remain within the guiding catheter or guiding sheath.
- Ensure the stent system is fully flushed with heparinized saline prior to use. Do not use the delivery system if flush is not observed exiting at the distal end of the sheath.
Magnetic Resonance Imaging (MRI) Compatibility
Through non-clinical testing, the Carotid WALLSTENT MonorailR Endoprosthesis (Carotid WALLSTENT Endoprosthesis), has been shown to be MRI safe at field strengths of 3.0 Tesla or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for15 minutes of MRI exposure. The Carotid WALLSTENT Endoprosthesis should not migrate in this MRI environment. Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3.0 Tesla. MRI at 3.0 Tesla or less may be performed immediately following the implantation of the Carotid WALLSTENT Endoprosthesis. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent. MR image artifact has been evaluated at 1.5 Tesla only.
POTENTIAL ADVERSE EVENTS
Based on the literature, and on clinical and commercial experience with carotid stents and embolic protection systems, potential adverse events include, but are not limited to the following:
- Abrupt vessel closure
- Additional interventional or surgical treatment (e.g., stenting or carotid endarterectomy)
- Allergic reactions (including to antiplatelet agents, contrast medium or stent materials)
- Angina/coronary ischemia
- Arteriovenous fistula
- Bacteremia or septicemia
- Cerebral vascular event such as edema
- Cerebral ischemia/transient ischemic attack
- Congestive heart failure (CHF)
- Detachment and/or implantation of a component
- Emboli (air, tissue, plaque, thrombus, device or other)
- Filter thrombosis/occlusion
- Hyperperfusion syndrome
- Ischemia/infarction of tissue or organ
- Myocardial Infarction (MI)
- Renal failure/insufficiency
- Restenosis of stented segment
- Severe unilateral headache
- Stent embolization
- Stent/filter entanglement or damage
- Stent migration
- Stent malposition
- Stent thrombosis/occlusion
- Stroke/cerebrovascular accident (CVA)
- Vessel injury/dissection/perforation/rupture/trauma
- Vessel occlusion or thrombosis
- Vessel spasm or recoil
Any device related adverse event involving the Carotid WALLSTENT R Monorail Endoprosthesis (Carotid WALLSTENT Endoprosthesis) should be reported immediately to Boston Scientific, Customer Service, at (888) 272-1001.