MULTI-LINK VISION® Coronary Stent System
Important Safety Information
The MULTI-LINK VISION RX and MULTI-LINK VISION OTW Coronary Stent Systems are indicated for improving coronary luminal diameter in the following (see Individualization of Treatment):
APPLIES TO MULTI-LINK VISION (RX and OTW), 3.0-4.0 mm ONLY:
- 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.
- Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length ≤ 25 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 ≤ 25 mm with a reference vessel diameter of 3.0 mm to 4.0 mm.
- Outcome (beyond 9 months) for this permanent implant is unknown at present.
APPLIES TO MULTI-LINK VISION (RX and OTW), 2.75 mm ONLY:
- 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 diameter of 2.75 mm.
CONTRAINDICATIONS (APPLIES TO ALL SIZES):
The MULTI-LINK VISION RX and MULTI-LINK VISION OTW Coronary Stent Systems are contraindicated for use in:
- Patients in whom anti-platelet and / or anti-coagulant 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 (APPLIES TO ALL SIZES, EXCEPT AS NOTED):
- · 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 cobalt chromium 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).
APPLIES TO MULTI-LINK VISION (RX and OTW), 2.75 mm ONLY, IN ADDITION TO ABOVE:
- Long term outcome of this permanent implant is unknown at present.
PRECAUTIONS (APPLIES TO ALL SIZES):
- · Nonclinical testing has demonstrated that the MULTI-LINK VISION (RX and OTW) CSS has been shown in non-clinical testing to be MRI safe immediately following implantation. They can be scanned safely under the conditions in the Instructions for Use.
- · The MULTI-LINK VISION (RX and OTW) CSS should be handled, placed, implanted, and removed according to the Instructions for Use.
POTENTIAL ADVERSE EVENTS
(APPLIES TO ALL SIZES EXCEPT AS NOTED):
Adverse events may be associated with the use of a coronary stent in native coronary arteries:
APPLIES TO ALL:
• Acute myocardial infarction • Death • Hypotension / hypertension • Restenosis of stented segment • Stent embolization • Stroke / cerebrovascular accident • Total occlusion of coronary artery
APPLIES TO MULTI-LINK VISION (RX and OTW) 3.0-4.0 mm ONLY:
• Arrhythmias, including VF and VT • Dissection • Drug reactions to anti-platelet agents / contrast medium • Emboli, distal (air, tissue or thrombotic emboli) • Emergent coronary artery bypass surgery • Hemorrhage, requiring transfusion • Infection and / or pain at insertion site • Ischemia, myocardial • Perforation • Pseudoaneurysm, femoral • Spasm • Stent thrombosis / occlusion
APPLIES TO MULTI-LINK VISION (RX and OTW) 2.75 mm ONLY:
• Allergic reaction to contrast • Arterial perforation • Arterial rupture •Arteriovenous fistula • Cardiac arrhythmias • Bleeding complications (including transfusions) • Coronary spasm • Dissection of the coronary artery • Drug reaction to antiplatelet agent • Emergency or non-emergent coronary artery bypass graft surgery • Entry site complications • Infection • Injury to the coronary artery • Ischemia • Pseudoaneurysm • Stent thrombosis / emboli • Unstable angina pectoris • Vascular complications
Prior to use, please reference the Instructions for use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions and adverse events.
AP2936451-US Rev. A (03/12)