Contraindications
The LIFESTENT® Vascular Stent System is contraindicated for use in:
• Patients with a known hypersensitivity to nitinol (nickel, titanium), and tantalum.
• Patients who cannot receive recommended anti-platelet and/or anti-coagulation 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
• DO NOT use if the temperature exposure indicator (i.e., square label found on the pouch) is black as the unconstrained stent diameter may have been compromised. The temperature exposure indicator label should be grey and must be clearly visible on the pouch.
• The LIFESTENT® Vascular Stent System is supplied sterile and is intended for single use only. DO NOT resterilize and/or reuse the device.
• DO NOT use if pouch is opened or damaged.
• DO NOT use the device after the "Use By" date specified on the label.
• Persons with allergic reactions to nickel titanium (nitinol) alloy may suffer an allergic response to this implant.
• DO NOT use with Enu000LTM or Lipiodol contrast media.
• DO NOT expose the delivery system to organic solvents (e.g., alcohol).
• The stent is not designed for repositioning or recapturing.
• Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures.
• If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol).
• The safety and effectiveness of stent overlapping in the middle (P2) and distal popliteal artery (P3) has not been established.
• The long-term outcomes following repeat dilatation of endothelialized stents are unknown.
Precautions
• The device is intended for use by physicians who have received appropriate training.
• The delivery system is not designed for use with power injection systems.
• Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.
• Prior to stent deployment, remove slack from the delivery system catheter outside the patient.
• If excessive force is felt during stent deployment, do not force the delivery system. Remove the delivery system and replace with a new unit.
• Store in a cool, dark, dry place.
• Do not attempt to break, damage, or disrupt the stent after placement.
• Cases of fracture have been reported in clinical use of the LIFESTENT's Vascular Stent. Cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment. Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture. The long-term clinical implications of these stent fractures have not yet been established (see section J).
• The safety and effectiveness of this device for use in treatment of instent restenosis has not been established.