CONTRAINDICATIONS
Use of the Cordis PRECISE PRO RX® Nitinol Stent Systemis contraindicated in the following patients:
• Patients in whom antiplatelet and or anticoagulation therapy is contraindicated.
• Patients in whom the guide catheter is unable to be placed.
• Patients with uncorrected bleeding disorders.
• Patients with known allergies to nitinol.
• Lesions in the ostium of the common carotid artery.
WARNINGS
• Only physicians who have received appropriate training for carotid stenting and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
• The safety and efficacy of the PRECISE® stent have not been demonstrated with embolic protection systems other than the Cordis ANGIOGUARD® device.
• The long-term performance (>3 years) of carotid stents has not yet been established.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture.
• The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• Overstretching of the artery may result in rupture and life-threatening bleeding.
• In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. aspirin) may be adversely affected.
• The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure.
• In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
Patient Selection Warnings
• Safety and effectiveness of the Cordis PRECISE PRO RX® Nitinol Stent System has NOT yet been established in patients with the characteristics noted below.
Device Use Warnings
• Use of smaller than indicated accessory device can lead to introduction of air into that device as the stent delivery system is advanced, which may not be removed during air aspiration.
• Do not use a leaflet-type valve with the sheath introducer/guiding catheter.
• Ensure that the catheter system is flushed according to the steps outlined in “Introduction of Stent Delivery System”. Failure to do so could result in air entering the sheath introducer/guiding catheter.
• Ensure that there is a tight seal between the PRECISE PRO RX® catheter and the valve for the sheath introducer/guiding catheter during aspiration. Failure to do so could result in air entering the accessory device.
• The black dotted pattern on the gray temperature exposure indicator found on the pouch must be clearly visible. Do not use if entire circle is completely black as the preprogrammed stent diameter may have been compromised.
• Do not use the device if there are abnormalities in the sterile barrier (e.g. broken seal, torn or breached barrier) or product.
• This device is intended for one-time use only. Do not re-sterilize and/or reuse. Structural integrity and/or function may be impaired through reuse or cleaning.
• Do not use the Cordis PRECISE PRO RX® Nitinol Stent System after the “Use By” date specified on the package.
• Do not use with Ethiodol or Lipiodol* contrast media, which may adversely affect the stent delivery system.
• Do not expose the delivery system to organic solvents (e.g. alcohol) as structural integrity and/or function of the device may be impaired.
• The stent is not designed for dragging or repositioning.
• Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture.
• When multiple stents are used, they should be of similar composition.
• Long-term outcomes following repeat dilatation of endothelialized stents are unknown.
PRECAUTIONS
Stent Handling Precautions
• The Cordis PRECISE PRO RX® Nitinol Stent System is supplied sterile and is intended for single use only. Do not resterilize and/or reuse the device.
• The Cordis PRECISE PRO RX® Nitinol Stent System is shipped with the Tuohy Borst valve in the open position. Care should be taken not to pre-deploy the stent. The device should be prepped in the tray.
• Do not use the Cordis PRECISE PRO RX® Nitinol Stent System after the “Use By” date specified on the package.
• Do not use if the pouch is opened or damaged.
• Store in a cool, dark, dry place.
Stent Placement Precautions
• Venous access should be available during carotid stenting in order to manage bradycardia and/or hypotension either by pharmaceutical intervention or placement of a temporary pacemaker, if needed.
• When catheters are in the body, they should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality images is needed.
• The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device performance.
• If resistance is met during delivery system introduction, the system should be withdrawn and another system used.
• Prior to stent deployment, remove all slack from the catheter delivery system.
• When treating multiple lesions, the distal lesion should be initially stented, followed by the proximal lesion. Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent, reducing the chance for dislodging stents that have already been placed.
• Overlap of sequential stents is necessary, but the amount of overlap should be kept to a minimum (approximately 5mm). In no instance should more than 2 stents overlap.
• Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. In the PRECISE® Stent, they have been reported most often in clinical uses for which the safety and effectiveness have not been established. The causes and clinical implications of stent fractures are not well characterized. Care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.
Post Stent Placement Precautions
• Recrossing a deployed stent with adjunct devices must be performed with caution.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
