CONTRAINDICATIONS

• Presence or suspected presence of severe atheromatous disease.
• Presence or suspected presence of unfavorable patient anatomy, such as vascular configurations that do not allow superselective catheter placement.
• Inadequate vessel diameter to accept emboli.
• Vascular resistance peripheral to the feeding vessels that will not allow emboli to be carried into the lesion.
• Inappropriate vascular anatomy such as feeding vessels smaller than the distal branches from which they emerge.
• Inappropriate vascular anatomy such as extra-to-intracranial anastomoses or shunts
• Inappropriate vascular anatomy such as the presence of collateral vessel pathways that, if embolized, could endanger normal tissues.
• Presence or likely onset of hemorrhage.
• Presence or likely onset of vasospasm
• Patient intolerance to temporary occlusion of targeted vessels
• Presence of target leading directly to cranial nerves.

WARNINGS

• Neurological deficit, ischemic stroke or ischemic infarct can occur from occlusion of normal vessels by emboli.
• Artificial embolization may not occlude all arteries feeding a large arteriovenous malformation. If treatment is incomplete, the possibility of subsequent hemorrhage and/or development of alternative feeding routes may persist.
• The packaging of this product contains natural rubber latex, which may cause allergic reactions.

PRECAUTIONS

• Small contaminating particles found on the angiography table may cause foreign body reactions or actual infection. The physician should use the utmost caution to avoid contaminants during preparation of the device for use.
• Use of angiography for preoperative evaluation, operative control and postoperative follow-up is recommended.
• Use of artificial embolization devices requires careful evaluation of the vascular network associated with the lesion.
• Smaller particles are reported to be more likely to cause cranial nerve palsies and ischemic infraction because of their ability to block vessels at the precapillary level. The physician's experience must be the final judge as to the amount of the device to use, the size of the particles to use, and even whether a treatment should be undertaken.
• The highest degree of caution is recommended in the presence of visible extra-to-intracranial shunts, and in the area of the cranial nerves.
• Performing therapeutic embolizations deliberately to occlude blood vessels is a high-risk procedure. Appropriate facilities should be available for coping with the potentials complications of the procedure.
• As with any surgical procedure, strict attention to sterile technique is required.
• Emboli of appropriate size must be selected by the physician, based upon the lesion to be treated and the measurements from angiography.
• As treatment progresses, the vessel will typically accept less emboli. Slowing or termination of emboli acceptance may occur when the vessel or lesion is occluded by prior emboli, or in the presence of vasospasm or severe atheromatous disease. Care must be taken to prevent continued infusion , as continued infusion may result in emboli reflux into normal vasculature, creating the potential of normal tissue ischemic infraction.
• Termination of emboli infusion is recommended prior to complete vessel occlusion
• The use of tapered tip delivery catheters is not recommended, as emboli may obstruct the catheter tip.

• Catheter tip thrombosis and subsequent dislodgment
• Spasm of the artery adjacent to the catheter tip
• Rupture of a nearby saccular aneurysm
• Passage of emboli into normal vessels adjacent to the treatment/delivery site
• Passage of emboli through the lesion and into normal vasculature, resulting in normal tissue damage.
• Reflux of emboli into normal vasculature, including arterial beds such as the internal carotid artery, pulmonary or coronary circulations, resulting in normal tissue damage.
• Subarachnoid hemorrhage from recurrent bleeding of a vascular malformations or from rupture of an associated aneurysm. The relationship between embolization and the appearance of aneurysms or other vascular lesions is unclear.
• Foreign body reactions necessitating medical intervention
• Infection necessitating medical intervention
• capillary bed saturation and tissue damage
• Ischemic stroke or ischemic infraction
• Vessel or lesion rupture resulting in hemorrhage
• Recurrent hemorrhage or vasospasm
• Vessel recanalization requiring re-treatment
• As with any embolization device, patient injury including permanent disability or death may occur as a result of its use