![]() Do not attempt to pull a partially expanded stent back through the sheath or guiding catheter dislodgment of the stent from the Delivery System may occur.If the thumbwheel moves freely in both directions after unlocking, remove the device together with the introducer sheath or guiding catheter as single unit do not use the unit as unintentional partial or full deployment may occur.Do not restrict retracting sheath during stent deployment. If detachable outer jacket is not engaged in the introducer sheath, manually stabilize prior to deployment to help ensure accurate stent delivery.Removing all slack from the delivery system prior to stent deployment will help ensure accurate stent delivery. Advance the Delivery System past the lesion and pull back to help remove slack from the system.Once unlocked, the retraction sheath may unintentionally release the stent during device manipulation.Once unlocked, the handle locking mechanism cannot be re-locked.Failure to follow this instruction could lead to deployment of the stent at an unintended location. Do not unlock the handle prior to positioning the stent at the intended location.If the thumbwheel moves prior to unlocking, do not use unit unintentional partial or full deployment may occur.Reattach by pushing the outer jacket back into the handle. ![]() Inspect to determine the outer jacket is attached to the handle.This is most important during Delivery System removal from packaging, mandrel removal, placement over guide wire, and advancement through rotating hemostatic valve (RHV) adapter and guiding catheter hub. Special care must be taken not to handle or in any way disrupt the stent on the Delivery System.Stent system is intended to perform as a system. Do not remove the stent from its Delivery System, as removal may damage the stent and / or lead to stent embolization.Stent Delivery System Handling – Precautions ![]() Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the vasculature. Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the Absolute Pro™ for their intended uses, contraindications, and potential complications. Do not remove the stent for use in conjunction with other dilatation catheters do not use the Absolute Pro™ in conjunction with other stents. The Absolute Pro™ is intended to perform as a system. Once the stent is apposed to the vessel, it is not recommended to remove the stent with the delivery system. The stent is not designed for repositioning once the stent has apposed the vessel wall. The stent is not designed for resheathing or recapturing. Only physicians familiar with the complications, side effects and hazards commonly associated with iliac stent placement should use this device. Avoid unnecessary handling, which may kink or damage the Delivery System. Do not use if the package is open or damaged. Use of appropriate anticoagulant and/or antiplatelet therapy per standard of care is recommended for use with this stent system. Use of an undersized guide wire, with insufficient support, may cause kinking in the Stent Delivery System. Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures. However, when multiple stents are required, stent materials should be of similar composition. The safety and effectiveness of multiple overlapping stents have not been established. ![]() nickel, titanium) may suffer an allergic reaction to this implant. Persons with known hypersensitivities to nitinol and / or its components (e.g. ![]() Use prior to the “Use By” date specified on the package. This device is intended for single-use only do not reuse. The Absolute Pro™ Vascular Self-Expanding Stent System is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm to 9.1 mm and lesion lengths up to 90 mm.ĭO NOT USE IF THE TEMPERATURE INDICATOR IS BLACK. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |