CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
INTENDED USE/INDICATIONS FOR USE
The VeriFLEX (Liberte) Over-The-Wire and Monorail Coronary Stent Systems are indicated for improving coronary luminal diameter in the following (see DFU 8.1 Individualization of Treatment):
• Patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length ≤ 28 mm) with a reference vessel diameter of 2.75 to 5.0 mm.
The VeriFLEX (Liberte) Stent is contraindicated for use in:
• Patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
• Patients with known allergies to stainless steel.
• The device carries an associated risk of subacute thrombosis, vascular complications, and/or bleeding events.
• Persons allergic to stainless steel 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 dilation of the arterial segment containing the stent. The long-term outcome following repeat dilation of coronary stents is unknown at present.
• Before withdrawing the Stent Delivery System (SDS), visually confirm complete balloon deflation by fluoroscopy (see Table 2 for Deflation Time Specifications).
• The VeriFLEX (Liberte) Coronary Stent System is designed for use as a unit.
• Use only the appropriate balloon inflation media Do not use air or any gas medium to inflate the balloon.
• 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 dilation, placement of additional stents, or other).
• When treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the more proximal lesion(s).
• Do not expand the stent if it is not properly positioned in the vessel..
• Placement of the stent has the potential to compromise side branch patency.
• Do not exceed rated burst pressure as indicated on product label.
• If unusual resistance is felt at any time during lesion access before stent implantation, the Stent System and the guiding catheter should be removed as a single unit.
• Do not attempt to pull an unexpanded stent back into the guiding catheter while engaged in the coronary arteries, as stent damage or stent dislodgment from the balloon may occur.
• An unexpanded stent should be introduced into the coronary arteries one time only. An unexpanded stent should not be subsequently moved in and out through the distal end of the guiding catheter as stent damage or stent dislodgment from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares and/ or forceps) may result in additional trauma to the vascular site.
POTENTIAL ADVERSE EVENTS (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to:
• Acute Myocardial Infarction
• Allergic reaction to antiplatelet agents/contrast media
• Arrhythmias, including ventricular fibrillation (VF) and ventricular tachycardia (VT)
• Emboli, distal (air, tissue or thrombotic emboli)
• Emergent Coronary Artery Bypass Surgery (CABG)
• Hemorrhage, requiring transfusion
• Infection and/or pain at the access site
• Perforation or Rupture
• Pseudoaneurysm, femoral
• Restenosis of stented segment
• Stent embolization
• Stent thrombosis/occlusion
• Stroke/cerebrovascular accident (CVA)/transient ischemic attack (TIA)
• Total occlusion of coronary artery