Medtronic
 
 

Vascular

Micro-Driver® Coronary Stent System

Intended Use

The Medtronic Micro-Driver MX2 Multi-Exchange/Over-the-Wire Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2.25–2.75 mm and ≤21 mm in length. Outcome beyond 270 days for this permanent implant is unknown at present.

Contraindications
  • Patients in whom antiplatelet and/or anticoagulation therapy is
    contraindicated.
  • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Warnings/Precautions
  • 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. Administration of appropriate anticoagulant, antiplatelet and coronary vasodilator therapy is critical to successful stent implantation and follow-up.
  • Patients allergic to F-562 cobalt-chromium alloy (alloy components include cobalt, chromium, or nickel) may suffer an allergic reaction to this implant.
  • Only physicians who have received appropriate training should perform implantation of the stent.
  • 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 coronary stents is unknown at present.
  • When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different materials in contact with each other may increase the potential for corrosion. Data obtained from in vitro corrosion tests using a F562 CoCr alloy stent (Medtronic Driver Coronary Stent) in combination with a 316L stainless steel alloy stent (Medtronic S7 Coronary Stent) do not suggest an increased risk of in vivo corrosion.
Adverse Events

Potential adverse events that may be associated with the use of a coronary stent in native coronary arteries in order of severity are death, emergency Coronary Artery Bypass Graft Surgery (CABG), stroke/cerebrovascular accidents, cardiac tamponade, stent thrombosis or occlusion, total occlusion of coronary artery, acute myocardial infarction, restenosis of stented segments, perforation, arrhythmias (including ventricular fibrillation and ventricular tachycardia), dissection, distal emboli (air, tissue or thrombotic emboli), stent embolization, hemorrhage requiring transfusion, femoral pseudoaneurysm, spasm, myocardial ischemia, hypotension/hypertension, allergic reaction to drugs/contrast medium/stent material, peripheral ischemia, peripheral nerve injury, infection and pain at the insertion site, and hematoma.

Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on
the order of a physician.

For further information, please call Medtronic at 1-888-283-7868.

Additional Information