CONTRAINDICATIONS
• Patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty PTA procedure.
• Patients with contraindication to antiplatelet and/or anticoagulation therapy.
• Patients who are judged to have a lesion that prevents proper placement or deployment of the stent.
• A lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion.
• A lesion through which a guide wire cannot pass.
WARNINGS
• Patients with known upper extremity vascular disease, extreme tortuosity, anomalous radial artery take off, severe subclavian stenosis or severe atherosclerosis.
• Patients with known Buerger's disease or Raynaud's phenomenon.
• Presence of Arterio-venous Fistula.
• Patients with known anatomical abnormalities of the upper extremity / aorta.
• Patients who are exceptionally tall with a radial artery (RA) to iliac artery (IA) length greater than 150 cm.
• Patients with known dissecting thoracoabdominal aortic aneurysm.
• The stent system has been sterilized by ethylene oxide gas, and is for single use only. Do not reuse. Do not resterilize. Do not reprocess as reprocessing may compromise the sterility, biocompatibility and functional integrity of this product.
• The stent system is sterile and non-pyrogenic in an unopened and undamaged unit package. Do not use if the unit package or the product has been damaged or soiled.
• Use this device prior to the expiry date indicated on the package.
• The stent should not come in contact with a previously placed non-nitinol stent. Contact of stents made from two dissimilar materials could possibly result in corrosion of the stents.
• Do not use in patients with known allergy to nickel-titanium alloy, gold or contrast media as this may result in an allergic reaction.
• Perform appropriate antiplatelet and/or anticoagulation therapy pre- and post- procedure.
• Insert the device into a guiding sheath or guiding catheter of adequate length to guide the device from the puncture site to the treatment site, failure to do so may cause thrombus on the vessel wall and/or plaque to flow through the blood stream, which may cause severe embolization and/or stroke especially in trans-brachial approach or trans-radial approach.
PRECAUTIONS
• Do not use on pregnant patients or patients who may become pregnant.
• Patients for a peripheral intervention should be selected carefully. Operators should bear in mind that complications including (but not limited to) subacute thrombosis, vessel complication and hemorrhagic complications may result from peripheral intervention.
• This device should be used only at institutions where emergency surgery can be performed due to the risk of severe complications.
• This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques, stent implantations, and transradial access.
• Confirm that the design of the stent system meets the criteria of the procedure and the technique to be used.
• If delivering stent from a transradial approach, standard departmental radial artery protocol should be followed to prevent radial artery occlusion, injury or spasm.
• Prior to beginning radial artery access, conduct a screening test such as an Allen test to ensure the radial access is appropriate for the patient.
• Choose the appropriate stent size by considering the regions in which diagnosis is performed, and the anatomical aspects.
• Use delivery system of adequate usable length for patient anatomy to deliver the device from the puncture site to the treatment site.
• Do not use in highly tortuous or highly calcified lesions and/or vessels proximal to the lesion which could prevent proper pre-dilatation.
• To avoid resistance while inserting the guide wire into the delivery system, wipe off any foreign material (including blood) on the guide wire before delivering the stent system.
• Do not use agents containing organic solvent (e.g. alcohol) or oil-based contrast agents (e.g. fatty acid of poppy seed oil ethyl ester iodide "Lipiodol® "), as this may cause the device to break or lose lubricity.
• Pre-dilatation of the target vessel is recommended.
• To assure optimal stent delivery, confirm that the pre-dilation is properly done before stenting patients who have highly tortuous or calcified lesions and/or vessels proximal to the lesion.
• To maintain sterility, the stent system should be used immediately after opening the package and be disposed of safely and properly after use.
• The entire operation should be carried out aseptically.
• Due to the diameter of the delivery system, buddy wire technique cannot be performed with a 6 Fr. introducer sheath or guiding catheter. Choose the introducer sheath or guiding catheter with sufficient inner lumen.
• Manipulate the stent system carefully within the artery. If you feel any resistance, stop manipulating the stent system and under high-resolution fluoroscopy try to determine the cause of the problem. Continuing to manipulate the stent system may result in damage to the vessel and/or damage of the stent system. This may necessitate retrieval of fragments of the stent system.
• Stenting across a major vessel branch may lead to compromised future diagnostic or therapeutic procedures.
• Care should be taken when advancing the stent system through a previously placed stent. The stent system may be caught in the previously placed stent, and may cause deformation and/or dislodgement of the stent, damage to the blood vessel, and/or thrombo-embolism.
• A partially deployed stent cannot be repositioned or retracted into the sheath. Retraction, or repositioning of a stent by force, could cause deformation of the stent, damage to the blood vessel and/or to the delivery catheter. The stent cannot be removed after implantation.
• If you feel any resistance during withdrawal of the delivery catheter after stent implantation, stop the procedure and determine the cause of resistance in order to alleviate the risk of damaging the delivery catheter. • Care should be given when additional devices and wires are delivered through a previously placed stent in order to prevent damage or dislodgement.
Important Safety Information
Do not use this device in patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, or a lesion through which a guide wire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques, stent implantation, and transradial access.
