Omnilink Elite™

INDICATIONS

The Omnilink Elite™ Stent System is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5.0 mm and ≤ 11.0 mm, and lesion lengths up to 50 mm.

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS

• This device is intended for single-use only; do not reuse. Do not resterilize. Do not use if package is open or damaged.
• Since the use of this device carries the associated risk of subacute thrombosis, vascular complications, and / or bleeding events, judicious selection of patients is necessary.
• Persons allergic to L605 cobalt chromium alloy may suffer an allergic reaction to this implant.
• This device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty and stent placement.
• The safety and effectiveness of multiple overlapping stents have not been established.  However, when multiple stents are required, stent materials should be of similar composition to avoid the potential for dissimilar metal corrosion.
• Use of appropriate anticoagulant and / or antiplatelet therapy per standard of care is recommended for use with this stent system.

PRECAUTIONS

The device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty and stent placement.

Stent Delivery System Handling – Precautions

• For single use only. Do not resterilize or reuse.
• Use the stent system prior to the “Use by” date specified on the package.
• Do not remove stent from its delivery balloon, as removal may damage the stent and / or lead to stent embolization.
• Carefully inspect the Omnilink Elite™ Stent System prior to use to verify that the stent has not been damaged in shipment and that the device dimensions are suitable for the specific procedure. Take care to avoid unnecessary handling.
• The Omnilink Elite™ Stent System is intended to perform as a system. The stent should not be removed for use in conjunction with other dilatation catheters, nor should the delivery system be used in conjunction with other stents.
• Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the Omnilink Elite™ Stent System, for their intended uses, contraindications, and potential complications.
• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during stent system removal from the packaging, placement over a guide wire and advancement through a guiding catheter or introducer sheath.
• Do not "roll" the mounted stent with your fingers, as this action may loosen the stent from the delivery balloon.
• Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon, as this may cause uneven expansion and difficulty in deployment of the stent.
• Do not advance the stent delivery system without the guide wire extending from the tip.

Stent Placement – Precautions

• Do not prepare or pre-inflate balloon prior to stent deployment other than as directed.  Use balloon purging technique described in the Clinician Use Information section.
• The inflated balloon diameter of the system used to deploy the stent should approximate the diameter of the vessel. Oversizing of the stent can result in a ruptured vessel. To ensure full expansion of the stent, the balloon should be inflated to a minimum of nominal pressure.
• 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 (surgical intervention, further dilatation, placement of additional stents, or other).
• When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the proximal stent.
• Do not expand the stent if it is not properly positioned in the vessel (see Stent / System Removal – Precautions).
• Stenting across a major bifurcation may hinder or prevent future side branch access.
• Balloon pressures should be monitored during inflation. Do not exceed Rated Burst Pressure (RBP) as indicated on product label. Use of pressures higher than specified on product label may result in a ruptured balloon with possible vessel damage or perforation.
• Stent retrieval methods (use of additional wires, snares, and / or forceps) may result in additional trauma to the vasculature and / or the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.
• The Omnilink Elite™ Stent System is intended for deployment and post-deployment dilatation of the stent only and should not be used to dilate other locations.
• Do not attempt to pull an unexpanded stent back through the introducer sheath / guiding catheter; dislodgment of the stent from the balloon may occur.
• Once fully deployed, the stent cannot be repositioned.

Stent / System Removal – Precautions

Should unusual resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.

When removing the delivery system as a single unit:

• DO NOT retract the delivery system into the introducer sheath / guiding catheter.
• Position the proximal balloon marker just distal to the tip of the introducer sheath / guiding catheter.
• Advance the guide wire in the anatomy as far distally as safely possible.
• Secure the delivery system to the introducer sheath / guiding catheter; then remove the introducer sheath / guiding catheter, guide wire and delivery system as a single unit.

Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components. If it is necessary to retain guide wire position for subsequent vessel access, leave the guide wire in place and remove all other system components.

Post Implant – Precautions

Exercise great care when crossing a newly deployed stent with a guide wire or balloon catheter to avoid disrupting the stent geometry.

Magnetic Resonance Imaging (MRI) Information

Non-clinical testing has demonstrated that the Omnilink Elite™ stent, in single and in overlapped configurations up to 100 mm in length, is MR Conditional as defined in ASTM F2503. It can be scanned safely under the conditions listed in the Instructions for Use.

POTENTIAL ADVERSE EVENTS

Potential complications associated with percutaneous iliac artery treatment, including the use of an iliac stent, may include, but are not limited to, the following:

• Acute myocardial infarction
• Allergic reaction (contrast medium, drug, or stent material)
• Aneurysm, pseudoaneurysm, or arteriovenous fistula
• Angina or coronary ischemia
• Arrhythmias, with or without the need for a temporary pacemaker
• Bleeding complications from anticoagulant or antiplatelet medication requiring transfusion or surgical intervention
• Death
• Detachment and / or implantation of a component of the system
• Embolization, arterial or other (air, tissue, plaque, thrombotic material, stent)
• Emergent or urgent surgery to perfuse limb or remove stent
• Fever
• Hematoma or hemorrhagic event
• Hypotension or hypertension
• Infection, local or systemic, including bacteremia or septicemia
• Ischemia or infarction of tissue or organ
• Pain (limb or catheter site)
• Pulmonary embolism
• Renal failure or insufficiency secondary to contrast medium
• Restenosis of vessel in stented segment
• Stent malapposition or migration
• Stent strut fracture
• Stent thrombosis or occlusion
• Stroke, cerebrovascular accident (CVA), or transient ischemic attack (TIA)
• Target limb loss (amputation of toe, foot, and / or leg)
• Vascular thrombosis or occlusion at puncture site, treatment site, or remote site
• Vessel dissection, perforation, or rupture
• Vessel spasm or recoil
• Worsening claudication or rest pain