EmPro™ Indications, Safety, and Warnings

Warnings and Precaution

Only physicians who have had appropriate training for carotid artery stenting and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.Refer to instructions supplied with all interventional devices to be used with the Empro™ EPS for their intended uses, contraindications, and potential complications.Safety and effectiveness of this device as an embolic protection system has not been established in coronary, cerebral or peripheral vasculatures.The Empro™ EPS is intended for one time use only. DO NOT re-sterilize and/or reuse it because it can potentially result in compromised device performance and risk of cross contamination.The appropriate antiplatelet, anticoagulant and if necessary, vasodilator therapy, must be used during the pre- and post-procedure to minimize the risk of embolism and thrombus.Avoid using power injection in the cerebral circulation.Introduce and advance devices slowly to prevent the embolism or trauma to the vasculature.Do not oversize or undersize the filter relative to the selected vessel diameter. This may result in inadequate vessel wall apposition or incomplete deployment of the filter. Undersizing or oversizing could cause no-flow or slow flow and/or embolism of debris.Overstretching of the artery may result in rupture and life-threatening bleeding.Minimize movement of the Empro™ EPS after initial placement. Excessive movement of the capture delivery wire may lead to embolization of debris, and vessel and/or device damage.Torqueing the capture delivery wire against resistance may cause filter damage, wire damage, delivery tip separation and wire whipping.Never withdraw or move an intravascular device against any resistance until the cause is determined. Applying excessive force during delivery or retrieval of the systems can potentially result in loss or damage to the devices and delivery components.Allow for and maintain adequate distance between the filter, the stent delivery system or deployed stent to avoid potential entanglement.Do not attempt to reposition or remove the capture delivery wire without the use of the retrieval catheter. This may lead to embolization of debris, and vessel and/or device damage.The maintenance of blood flow through the filter device should be observed throughout the procedure by use of fluoroscopy.PRECAUTIONSCarefully inspect the sterile package and the Empro™ EPS prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components, or if the package is opened or damaged.See the product label for shelf life. Do not use the Empro™ EPS beyond the labeled use by date.Confirm the compatibility of the Empro™ EPS with the interventional devices before actual use.Fully flush the Empro™ EPS filter and rapid exchange (Rx) guidewire lumen of the delivery catheter. Do not use the delivery system if flush is not observed exiting at the Rx delivery catheter proximal port location.Identify the delivery catheter and the primary 0.014” guidewire while advancing. Do not rotate the delivery catheter which can cause the primary wire to wrap around the catheter.Use caution when withdrawing the Empro™ EPS through the deployed stent. This may cause stent/filter entanglement, rupture and/or stent dislocation.After use, dispose in accordance with hospital, administrative and/or local government policy.Store in a cool and dry location.