Stent deformation, collapse, or fracture.Peripheral ischemia/peripheral nerve injury.Emergency surgery: peripheral vascular or coronary bypass.Embolism (air, tissue, device or thrombus).Coronary artery occlusion, perforation, rupture or dissection.Arrhythmias, including ventricular fibrillation.Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF).Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating).Access site pain, hematoma or hemorrhage.These risks (in alphabetical order) may include but are not limited to: Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. The safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid or peripheral vasculature. Patients with longer than 24 months of follow-up.Patients with a left ventricular ejection fraction of 2.5mg/dl.Patients with occluded target lesions including chronic total occlusions.Patients with moderate or severe lesion calcification at the target lesion.Patients with tortuous vessels in the region of the target vessel or proximal to the lesion.Patients with diffuse disease or poor flow distal too identified lesions.Patients with lesions located in a saphenous vein graft, in the left main coronary artery, ostial lesions, or bifurcation lesions.Patients with vessel thrombus at the lesion site.
Patients with evidence of an acute MI within 72 hours of intended stent implantation.Patients with coronary artery lesions longer than 27 mm or requiring more than one Resolute Integrity stent.Patients with coronary artery reference vessel diameters of 4.20 mm.Patients with target lesions which were treated with prior brachytherapy or the use of brachytherapy to treat in-stent restenosis of a Resolute Integrity stent.The safety and effectiveness of the Resolute Integrity stent have not yet been established in the following patient populations: Data from the RESOLUTE clinical trials have been prospectively evaluated and adjudicated using the definition developed by the Academic Research Consortium (ARC). Stent thrombosis is a low-frequency event that is frequently associated with MI or death.Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage Care should be taken to control the position of the guide catheter tip during stent delivery, deployment, and balloon withdrawal.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, myocardial infarction (MI), or death.
When drug-eluting stents (DES) are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the RESOLUTE pivotal clinical trials.Do not expose or wipe the product with organic solvents such as alcohol.The risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to contrast agents.
The long-term outcome following repeat catheter-based treatments of previously implanted endothelialized stents is not well characterized.