Carotid WALLSTENT® Monorail® Endoprosthesis

Prescriptive Information

Indications for Use

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 following criteria:

• 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 4.0mm and 9.0mm at the target lesion.

Contraindications

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.

General Warnings

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 guide wire 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 1mm to 2mm 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 life-threatening bleeding.
• Balloon angioplasty of the carotid bifurcation may initiate transient hemodynamic instability consisting of bradycardia or hypotension. Appropriate pharmacologic therapy must be immediately available.

Precautions

Through non-clinical testing, the Carotid WALLSTENT Monorail 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 2.0W/kg for 15 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.

Adverse Events

Death due to any cause • Life-threatening condition (e.g., stroke) • Persistent or significant disability/incapacity • Any event resulting in an unscheduled in-patient hospitalization or prolongation of existing hospitalization >72 hours post index procedure • Any event requiring intervention, except for comorbid scheduled events, which are scheduled and planned during the follow-up period • Congenital abnormality or birth defect. • Serious adverse events have been coded using the Medical Dictionary for Regulatory Activities (MedDRA™) version 5.0 and are presented by System Organ Class and Preferred Term as follows: • BLOOD AND LYMPHATIC SYSTEM DISORDERS include events such as anemia. • CARDIAC DISORDERS include events such as angina, arrhythmias, cardiac failure congestive and myocardial infarction. • EYE DISORDERS include events such as retinal infarction. • GASTROINTESTINAL DISORDERS include events such as gastrointestinal hemorrhage and retroperitoneal hemorrhage. • GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS include events such as death, multi-organ failure and pyrexia. • HEPATOBILIARY DISORDERS include events such as cholelithiasis. • INFECTIONS AND INFESTATIONS include events such as pneumonia, sepsis and urinary tract infection. • INJURY, POISONING AND PROCEDURAL COMPLICATIONS include events such as hip fracture and stent occlusion. • INVESTIGATIONS include events such as blood creatinine increased and neurological examination abnormal. • METABOLISMAND NUTRITION DISORDERS include events such as dehydration and hyperglycemia. • MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS include events such as arthritis and pain. • NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCLUDING CYSTS AND POLYPS) include events such as carcinomas, lung cancer and neoplasms. • NERVOUS SYSTEM DISORDERS include events such as cerebral hemorrhage, cerebrovascular accident, convulsions, dizziness, syncope and transient ischemic attack. • PSYCHIATRIC DISORDERS include events such as confusion, depression and mental status changes. • RENAL AND URINARY DISORDERS include events such as renal failure and impairment. • REPRODUCTIVE SYSTEMAND BREAST DISORDERS include events such as vaginal hemorrhage. • RESPIRATORY,THORACIC AND MEDIASTINAL DISORDERS include events such as chronic obstructive airway disease, dyspnea, pulmonary fibrosis and respiratory failure. • SKIN AND SUBCUTANEOUS TISSUE DISORDERS include events such as skin ulcer. • SURGICAL AND MEDICAL PROCEDURES include events such as aortic valve replacement, arterial stent insertion, carotid endarterectomy, coronary artery surgery and revascularization, and hip arthroplasty. • VASCULAR DISORDERS include events such as hematoma, hemorrhage, hypertension, hypotension, peripheral revascularization and vascular pseudoaneurysm.

Potential Adverse Events

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) • Aneurysm • Angina/coronary ischemia • Arrhythmia • Arteriovenous fistula • Bacteremia or septicemia • Bleeding • Bradycardia • Cerebral vascular event such as edema • Cerebral ischemia/transient ischemic attack • Congestive heart failure (CHF) • Death • Detachment and/or implantation of a component • Emboli (air, tissue, plaque, thrombus, device or other) • Fever • Filter thrombosis/occlusion • Hematoma • Hemorrhage • Hyperperfusion syndrome • Hypotension hypertension • Hypotonia • Infection • Ischemia/infarction of tissue or organ • Myocardial Infarction (MI) • Pain • Pseudoaneurysm • Renal failure/insufficiency • Restenosis of stented segment • Seizure • 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.

Caution

Refer to the Directions for Use for a complete listing of precautions related to device use prior to stent implantation with the Carotid WALLSTENT Endoprosthesis.

• Do not hold the sheath or stent during stylus removal.
• The Carotid WALLSTENT Endoprosthesis is not compatible with any guide wire larger than 0.014 in (0.36 mm).
• For best device performance, the guide wire exit notch should remain within the guiding catheter or guiding sheath.
• Ensure the stent system is fully flushed with heparanized saline prior to use. Do not use the delivery system if flush is not observed exiting at the distal end of the sheath.
• 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.

Caution: Federal U.S. Law restricts this device to sale by or on the order of a physician.