MULTI-LINK MINI VISION Coronary Stent System

INDICATIONS

The MULTI-LINK MINI VISION RX and MULTI-LINK MINI VISION OTW Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel diameters from 2.0 mm to 2.5 mm.

CONTRAINDICATIONS

The MULTI-LINK MINI VISION Coronary Stent Systems are contraindicated for use in:

• Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.

WARNINGS AND PRECAUTIONS

WARNINGS

Long term outcome for this permanent implant is unknown at present.

• Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications and / or bleeding events.
•  Persons allergic to L-605 CoCr alloy (including the major elements cobalt, chromium, tungsten, nickel) may suffer an allergic reaction to this implant.
• Implantation of the stent should be performed only by physicians who have received appropriate training.
• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed.
• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized stents is unknown at present.
• When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different metals in contact with each other may increase the potential for corrosion. The risk of in vivo corrosion does not appear to increase based on in vitro corrosion tests using an L-605 CoCr alloy stent (MULTI-LINK VISION Coronary Stent) in combination with a 316L stainless steel alloy stent (MULTI-LINK TETRA Coronary Stent).

Stent Handling – Precautions

• For single use only. Do not resterilize or reuse. Note the product "Use By" date.
• Do not remove the stent from its delivery system as removal may damage the stent and / or lead to stent embolization. Stent system is intended to perform together as a system.
• Delivery system should not be used in conjunction with other stents.
• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during catheter removal from packaging, placement over guide wire and advancement through rotating hemostatic valve adapter and guiding catheter hub.
• Do not manipulate (e.g., "roll") the stent with your fingers, as this action may loosen the stent from the delivery balloon.
• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon, as this may cause uneven expansion and difficulty in deployment of the stent.

Stent Placement – Precautions
• Do not prepare or pre-inflate delivery system prior to stent deployment other than as directed. Use balloon purging technique described in Delivery System Preparation.
• 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 (CABG, further dilatation, placement of additional stents, or other).
• When treating multiple lesions, stent the distal lesion prior to stenting the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent, and reduces the chance of dislodging the proximal stent.
• Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal – Precautions.)
• Placement of a stent has the potential to compromise side branch patency.
• Do not exceed the Rated Burst Pressure as indicated on the product label. Monitor balloon pressures during inflation. Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and dissection.
• An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in and out through the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the undeployed stent back into the guiding catheter. Should any resistance be felt at any time during withdrawal of the Coronary Stent System, the entire system should be removed as a single unit.
• Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the coronary vasculature and / or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.

Stent / System Removal – Precautions
Should any 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 guiding catheter.
• Position the proximal balloon marker just distal to the tip of the guiding catheter.
• Advance the guide wire into the coronary anatomy as far distally as safely possible.
• Tighten the rotating hemostatic valve to secure the delivery system to the guiding catheter; then remove the guiding catheter 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 artery / lesion access, leave the guide wire in place and remove all other system components.

Post Implant – Precautions
When crossing a newly deployed stent with a guide wire, balloon or delivery system, exercise care to avoid disrupting the stent geometry.

MRI (Magnetic Resonance Imaging) Statement
The MULTI-LINK MINI VISION stent has been shown in non-clinical testing to be MRI safe immediately following implantation. MRI test conditions used to evaluate this stent were: for magnetic field interactions, a static magnetic field strength of 3 tesla with a maximum spatial gradient magnetic field of 3.3 tesla/meter; for MRI-related heating, a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. While a single stent produced a temperature rise of less than 0.6°C and should not migrate under these conditions, the response of overlapping stents or stents with fractured struts is unknown. Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3 tesla. 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.

Potential Adverse Events
Adverse events may be associated with the use of a coronary stent in native coronary arteries:

• Acute myocardial infarction
• Allergic reaction to contrast
• Arterial perforation
• Arterial rupture
• Arteriovenous fistula
• Cardiac arrhythmias
• Bleeding complications (including transfusions)
• Coronary spasm
• Death
• Dissection of the coronary artery
• Drug reaction to antiplatelet agent
• Emergency or non-emergent coronary artery bypass graft surgery
• Entry site complications
• Hypotension / hypertension
• Infection
• Injury to the coronary artery
• Ischemia
• Pseudoaneurysm
• Restenosis of the stented segment
• Stent embolization
• Stent thrombosis / emboli
• Stroke / cerebrovascular accident
• Total occlusion of the coronary artery
• Unstable angina pectoris
• Vascular complications