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

The Omnilink Elite™ Peripheral Stent System is contraindicated for use in:

• Patients with a contraindication for antiplatelet / or anticoagulant therapy.
• Patients with a known hypersensitivity to stent materials (cobalt, chromium, tungsten, nickel), or contrast medium who cannot be adequately premedicated.
• Aneurysms immediately adjacent to the stent implantation site.
• Presence of fresh, unlysed, unorganized thrombus or embolic material.
• Target lesions that are resistant to complete balloon inflation.

WARNINGS

• Do not use if package is open or damaged or if it is suspected that the sterility for the device has been compromised. For single patient use only. DO NOT REUSE, REPROCESS OR RESTERILIZE.
• Use this device by the “Use by” (expiration) date as specified on the device package label.
• Judicious selection of patients is necessary, since the use of this device carries the associated risk of thrombosis, vascular complications, and / or bleeding events.
• This device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty.
• Stent placement should be performed in centers where surgery is readily available.
• Insertion and implantation of the Omnilink Elite™ Stent System should be performed only under fluoroscopic observation with radiographic equipment providing high resolution images.
• 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 Omnilink Elite™ Stent System be used in conjunction with other stents.
• Once fully deployed, the stent cannot be repositioned. Use of appropriate anticoagulant and / or antiplatelet therapy per standard of care is recommended for peripheral use of this stent system.
• Use of appropriate anticoagulant and / or antiplatelet therapy per standard of care is recommended for peripheral use of this stent system.

PRECAUTIONS

General – Precautions

• Subsequent restenosis may require repeat dilatation of the vessel segment containing the stent. The long-term outcome following repeat dilatation of endothelialized Omnilink Elite™ Stent System is unknown at present.
• Safety and effectiveness have not been studied in patients with poor renal function, pregnancy, lactating mother, pediatric population, and / or fibromuscular dysplasia.
• To avoid the possibility of dissimilar metal corrosion, do not implant stents of different metals in tandem where overlap or contact is possible, with an exception of stents made of 316L stainless steel and cobalt chromium which are compatible with stents made of nickel titanium alloy.
• This device is not designed for use with contrast media injection systems or power injection systems.
• The flexible design of the Omnilink Elite™ Peripheral Stent may result in variation in the deployed stent length.
• Refer to the product label for expanded stent outer diameter, nominal deployment pressure, and Rated Burst Pressure (RBP).
• 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. If gaseous medium is used and balloon rupture occurs, there is the potential of causing air embolism and / or vessel injury.
• The expanded stent outer diameter 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.
• 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.
• Balloon pressures should be monitored during inflation. Do not exceed Rated Burst Pressure (RBP) as indicated on the product label. Use of pressures higher than specified on the product label may result in a ruptured balloon with possible vessel damage or perforation.
• Estimated vessel reference size should not be less than 4.0 mm in diameter or bigger than 11.0 mm in diameter.
• The safety and effectiveness of the Omnilink Elite™ Stent System in patients with prior brachytherapy of the target lesion, or the use of brachytherapy for treated site restenosis in the Omnilink Elite™ Stent System, have not been established. Both vascular brachytherapy and the Omnilink Elite™ Stent System alter arterial remodeling. The potential combined effect on arterial remodeling by these two treatments is not known.
• Persons with known history of allergies to any of the components of this device listed below may suffer an allergic reaction to the Omnilink Elite™ Stent System. Prior to its use on the patient, the patient should be counseled on the material contained in the device and a thorough history of allergies must be discussed. This device contains cobalt-chromium alloy (cobalt, chromium, tungsten, nickel), polyamide and polyether block amide copolymer, polycarbonate, polyethylene, and silicone coating.

Stent Delivery System Handling – Precautions

• Do not remove the stent from its delivery system, as removal may damage the stent and / or lead to stent embolization. The Omnilink Elite™ Stent System is intended to perform as a system.
• 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.
• 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.
• Do not "roll" the mounted stent with your fingers, as this action may loosen the stent from the delivery balloon.
• Do not use if the stent is partially deployed upon removal from the package, or before starting the deployment procedure.
• Never advance the medical device 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 8.0 Clinician Use Information section.
• Implanting a stent may lead to dissection or perforation 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 diagnostic or therapeutic procedures.
• Stent retrieval methods (use of additional wires, snares, and / or forceps) may result in additional trauma to the vessel and / or the access site. Complications may include bleeding, hematoma, and / or pseudoaneurysm.
• Do not attempt to pull an unexpanded stent back through the introducer sheath; dislodgment of the stent from the balloon may occur.
• Failure to predilate the vessel may impair nominal / optimal stent delivery.
• Placement of a stent has the potential to compromise side branch patency.

Stent / System Removal – Precautions

When removing the delivery system as a single unit:

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

Failure to follow these steps and / or applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and / or stent delivery system components.

Should unusual resistance be felt at any time during stent system advancement, deployment or retraction of the stent, the entire system should be removed together with the introducer sheath as a single unit. If possible, retain the guide wire position for subsequent vessel access. Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and stent delivery system components, or damage to the vessel. If it is necessary to retain the guide wire position for subsequent artery / lesion access, leave the guide wire in place and remove all other system components.

Post Implant – Precautions

Great care must be exercised when crossing a newly deployed stent with a guide wire or balloon catheter to avoid disrupting the stent geometry.

If the patient requires imaging, see 6.5 Magnetic Resonance Imaging (MRI) Safety Information section.

CAUTION: Information must be supplied to the patient with an implanted device by way of an implant card. (See 10.0 Patient Implant Card section).

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 include, but are not limited to, the following:

• Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, stent material (cobalt, chromium, tungsten, nickel), and drug reactions to anticoagulation or antiplatelet drugs
• Vascular access complications which may require transfusion or vessel repair, including:
  • Catheter site reactions
  • Arteriovenous fistula
  • Pseudoaneurysm
  • Dissection
  • Bleeding (ecchymosis, oozing, hematoma, hemorrhage)
• Target artery complications which may require additional intervention, including:
  • Total occlusion or abrupt closure
  • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture
  • Embolism (air, tissue, plaque, thrombotic material, or device)
  • Artery or stent thrombosis
  • Stenosis or restenosis
  • Vessel spasm
• Major bleeding (non-access site)
• Venous thromboembolism (including pulmonary embolism)
• Cardiac arrhythmias (including conduction disorders, atrial, and ventricular arrhythmias)
• Cardiac ischemic conditions (including myocardiaI ischemia, myocardial infarction, and unstable or stable angina pectoris)
• Stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA)
• System organ failures:
  • Cardiac failure
  • Respiratory failure
  • Pulmonary edema
  • Renal failure
  • Shock
  • Cardiorespiratory arrest
• Blood cell disorder
  • lncluding heparin induced thrombocytopenia and other coagulopathy
• Hypotension / hypertension
• Peripheral nerve injury, neuropathy
• Claudication
• Tissue necrosis / ischemia
  • Tissue necrosis
  • Gangrene
  • Ulcer
  • Limb ischemia
  • Amputation
• Infection – local and systemic (including postprocedural)
• Nausea and vomiting
• Fever
• Pain
• Reperfusion syndrome / injury – limb
• Death
• Device-related complications:
  • Foreshortening
  • Stent angulation
  • Longitudinal deformation