Indications, Safety & Warnings

Intended Use

The Medtronic Driver Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3.0 mm to 4.0 mm and ≤30 mm in length using direct stenting or predilatation.

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 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.
• If the physician encounters difficulty while trying to cross the lesion by direct stenting and determines the lesion to be uncrossable, this patient should be treated per predilatation practice. The stent (the same stent if undamaged) or a new stent of the same kind should then be advanced and deployed with predilatation.
• Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation, placement of additional stents or other).
• Outcomes (beyond 270 days) for this permanent implant are unknown at present.

Adverse Events

Potential adverse events that may be associated with the use of a coronary stent in native coronary arteries (including those listed in the Driver Instructions for Use) are death, myocardial infarction, emergency coronary artery bypass graft surgery (CABG), stent thrombosis, bleeding complications, stroke/cerebrovascular accidents, vascular complications, stent failures, acute myocardial infarction, myocardial ischemia, arrhythmias (including ventricular fibrillation and ventricular tachycardia dissection), distal emboli (air, tissue or thrombotic emboli), hemorrhage requiring transfusion, perforation, restenosis of stented segments, stent embolization, total occlusion of coronary artery, cardiac tamponade, femoral pseudoaneurysm, spasm, 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.

Micro-Driver^® Coronary Stent Systems

Intended Use

The Medtronic Micro-Driver 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.