MULTI-LINK ZETA Coronary Stent Systems

INDICATIONS

The MULTI-LINK RX ZETA and MULTI-LINK OTW ZETA Coronary Stent Systems are indicated for improving coronary luminal diameter in the following (See Individualization of Treatment):
 

• Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length ≤ 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.
• Note: The 33 mm and 38 mm length stents are not indicated for de novo or restenotic native coronary artery lesions.
• Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length ≤ 35 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm.
• Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length ≤ 35 mm with a reference vessel diameter of 2.5 mm to 4.0 mm.
• Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (length ≤ 35 mm) with reference vessel diameters ranging from 2.5 mm to 4.0 mm.

CONTRAINDICATIONS
The MULTI-LINK RX ZETA and MULTI-LINK OTW ZETA 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 (See Individualization of Treatment):

WARNINGS

• 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).
• 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 316L stainless steel (including the major elements iron, chromium, nickel, molybdenum) 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.

Stent Handling – Precautions

• For single use only. Do not resterilize or reuse. Note the product "Use By" date.
• Do not remove stent from its delivery system as removal may damage the stent and / or lead to stent embolization. Stent system is intended to perform 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 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.

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 the section 9.3.2 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 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.)
• Placement of a stent has the potential to compromise side branch patency.
• Do not exceed Rated Burst Pressure as indicated on product label. Balloon pressures should be monitored 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, remove the entire system 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, remove the entire system 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

• Care must be exercised when crossing a newly deployed stent with a coronary guide wire, balloon or delivery system to avoid disrupting the stent geometry.
• The MULTI-LINK ZETA Coronary 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
• Arrhythmias, including VF and VT
• Death
• Dissection
• Drug reactions to antiplatelet agents / contrast medium
• Emboli, distal (air, tissue or thrombotic emboli)
• Emergent coronary artery bypass surgery
• Hemorrhage, requiring transfusion
• Hypotension / hypertension
• Infection and pain at insertion site
• Ischemia, myocardial
• Perforation
• Pseudoaneurysm, femoral
• Restenosis of stented segment
• Spasm
• Stent embolization
• Stent thrombosis / occlusion
• Stroke / cerebrovascular accident
• Total occlusion of coronary artery