Important Safety Information
This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (877) 526-7890.
- Driver® Coronary Stent System
- Medtronic Vascular Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW) or Multi-Exchange II (MX2) Stent Delivery Systems
Driver® Coronary Stent System
Intended Use
- The Medtronic Driver MX2/Over-the-Wire Coronary Stent Delivery 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.
For further information, please call Medtronic at 1-888-283-7868.
Medtronic Vascular Endeavor Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW) or Multi-Exchange II (MX2) Stent Delivery Systems
For complete Endeavor Instructions For Use, including Pre- and Post-Procedure Antiplatelet Regimen please download Instructions For Use (IFU) document
Indications
The Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW) or Multi-Exchange® II (MX2) Stent Delivery System is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary arteries with reference vessel diameters of ≥2.5 mm to ≤3.5 mm.
Contraindications
The Endeavor Zotarolimus-Eluting Coronary Stent System is contraindicated for use in:
- Patients with a known hypersensitivity to zotarolimus or structurally-related compounds
- Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum)
- Patients with a known hypersensitivity to Phosphorylcholine polymer or its individual components.
Coronary artery stenting is contraindicated for use in:
- Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
Warnings
- Please ensure that the inner package has not been opened or damaged, as this indicates the sterile barrier has been breached
- The use of this product carries the risks associated with coronary artery stenting, including subacute thrombosis, vascular complications, and/or bleeding events
- This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy
- During guidewire exchange, the wire should be manipulated while under high-quality fluoroscopic observation. Failure to do so may result in the wire moving into the vessel resulting in damage to the vessel wall.
Precautions
- Only physicians who have received adequate 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 stent blockage may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized stents is not well characterized
- Risks and benefits of the stent should be assessed for patients with history of severe reaction to contrast agents
- Do not expose or wipe the product with organic solvents such as alcohol or detergents
- Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Stent thrombosis is frequently associated with myocardial infarction (MI) or death. Data from the ENDEAVOR randomized clinical trials have been prospectively evaluated and adjudicated using both the protocol definition of stent thrombosis and the definition developed by the Academic Research Consortium (ARC), and demonstrate specific patterns of stent thrombosis that vary depending on the definition used. In the ENDEAVOR clinical trials analyzed to date, the differences in the incidence of stent thrombosis observed with the Endeavor stent compared to bare metal stents have not been associated with an increased risk of cardiac death, MI, or all-cause mortality. Additional data from longer-term follow-up in the ENDEAVOR randomized clinical trials and analyses of DES-related stent thrombosis are expected and should be considered in making treatment decisions as data become available
- When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the pivotal clinical trials
- Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
The safety and effectiveness of the Endeavor stent have not yet been established in the following patient populations:
- Women who are pregnant or lactating
- Men intending to father children
- Pediatric patients
- Patients with vessel thrombus at the lesion site
- Patients with coronary artery reference vessel diameters <2.5 mm or >3.5 mm
- Patients with coronary artery lesions longer than 27 mm or requiring more than one Endeavor stent
- Patients with lesions located in saphenous vein grafts, in the unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation
- Patients with diffuse disease or poor flow distal to the identified lesions
- Patients with multivessel disease
- Patients with tortuous vessels in the region of the obstruction or proximal to the lesion
- Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow
- Patients for longer than 48 months of follow-up
- Patients with in-stent restenosis
- Patients with moderate or severe calcification in the lesion or a chronic total occlusion
- Patients with prior brachytherapy of the target lesion or the use of brachytherapy to treat in-stent restenosis in an Endeavor stent.
The safety and effectiveness of the Endeavor stent have not been established in the cerebral, carotid, or peripheral vasculature.
Potential Adverse Events
Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks may include, but are not limited to
- Abrupt vessel closure
- Access site pain, hematoma or hemorrhage
- Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating)
- Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF)
- Arrhythmias
- Balloon rupture
- Cardiac tamponade
- Coronary artery occlusion, perforation, rupture, or dissection
- Coronary artery spasm
- Death
- Embolism (air, tissue, device, or thrombus)
- Emergency surgery: peripheral vascular or coronary bypass
- Failure to deliver the stent
- Hemorrhage requiring transfusion
- Hypotension/hypertension
- Incomplete stent apposition
- Infection or fever
- Late or very late thrombosis
- Myocardial infarction (MI)
- Myocardial ischemia
- Peripheral ischemia/peripheral nerve injury
- Renal failure
- Restenosis of the stented artery
- Rupture of native or bypass graft
- Shock/pulmonary edema
- Stent deformation, collapse, or fracture
- Stent migration
- Stent misplacement
- Stroke/transient ischemic attack
- Thrombosis (acute and subacute)
- Unstable angina
- Ventricular fibrillation.
Adverse Events Related to Zotarolimus
Patients' exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include
- Anemia
- Application site reaction
- Diarrhea
- Dry skin
- Headache
- Hematuria
- Infection
- Injection site reaction
- Pain (abdominal, arthralgia, injection site)
- Rash.
Please reference appropriate product Instructions for Use for more information regarding indications, warnings, precautions and potential adverse events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Last updated: 3 Aug 2008