Abbott RX Accunet Manual Del Usuario página 4

WARNING: During positioning, advance the RX Accunet EPS guide wire with filter basket and the delivery sheath as a unit.
Advancing the guide wire independently from the delivery sheath may result in premature filter deployment.
WARNING: When introducing the delivery system, confirm that the wire tip is free within the vessel lumen and is not directed
against the vessel wall. Failure to do so may result in vessel trauma. Use the radiopaque marker on the interventional device to
confirm position.
WARNING: Always advance or withdraw the RX Accunet EPS guide wire slowly using fluoroscopy to observe corresponding wire
movement and tip movement in particular. Never push, auger, retract or torque a guide wire that meets resistance. If the wire tip
becomes entrapped within a lesion or a device, such as a deployed stent, do NOT torque the guide wire. Determine the cause of
resistance and take necessary remedial action. Torquing or retracting the guide wire against resistance may damage the wire,
cause wire tip separation, or may cause vessel trauma. Resistance may be felt and / or observed using fluoroscopy by
noting any buckling of the guide wire tip.
Note: A variety of techniques can be used to assist passage of the delivery system if it has difficulty advancing through the lesion. Some options to
aid passage of the delivery system are:
• Have the patient rotate her / his neck from side-to-side. This motion may re-orient the carotid artery.
• If the RX Accunet EPS delivery system cannot cross the lesion, a 2 mm balloon may be used to predilate the lesion.
• If desired, insert a stiff 0.014" guide wire (buddy wire) to straighten the carotid vasculature to aid advancement of the delivery system.
Leave the buddy wire in place while advancing the RX Accunet EPS delivery system. Remove the buddy wire prior to deployment of the RX
Accunet EPS filter basket.
Filter Basket Positioning and Deployment
1. Position the delivery system in the artery such that the radiopaque markers are distal to the lesion to be treated.
CAUTION: For proper positioning of the filter basket, the vessel distal to the lesion should have an absence of excessive
tortuosity and be of adequate length (approximately 4 cm distal to the lesion and proximal to the petrous portion of
the vessel).
2. Loosen the torque device from the wire.
3. Feed the proximal, light blue end of the delivery sheath into the adjacent port of the peel away adapter on the torque device (see Figure 5).
Advance the torque device until it abuts against the darker blue part of the sheath where the slit in the sheath begins. Tighten down the
torque device to the wire.
Peel away adapter
Collet tube
Proximal End of Delivery Sheath Inserted in Peel Away Adapter
4. Remove all slack from the system.
Note: If using a long sheath with a hemostasis valve or if using the Abbott Vascular CoPilot Bleedback Control Valve, advance and reposition
the introducer tool within the valve to hold it in an open position. This will allow the delivery sheath to move freely within the valve.
5. Stabilize the torque device with one hand (preferably the left) and keep that hand resting over the delivery sheath, distal to the torque device.
With the other hand (the right), grab the proximal, light blue end of the delivery sheath that has been fed through the peel away adapter.
6. Under fluoroscopy pull the end of the sheath approximately 3 cm in a horizontal direction away from the patient. The sheath will peel away as
it is pulled through the adapter. Observe filter basket expansion.
CAUTION: Ensure that the torque device is secured tightly to the guide wire to avoid difficulties with deployment. If the torque
device is not tightened securely on the guide wire, proper deployment may not occur.
Note: Avoid excessive movement of the filter basket during unsheathing by removing all slack between the patient, guiding catheter / sheath
and delivery system.
Note: Slight advancement of the guide wire during the unsheathing of the filter basket may be required to avoid excess movement of the filter
basket during unsheathing.
7. The filter basket should now be fully expanded within the vessel. While maintaining a stable guide wire position, continue to peel back and
retract the delivery sheath from the wire using the peel away feature. When the light blue, distal section exits the guiding catheter, close the
RHV. The light blue, distal section will not peel. Once it exits the RHV, remove the torque device and the remaining portion of the delivery
sheath.
Note: If using a long sheath with a hemostasis valve, remove the introducer tool after the light blue, distal section of the delivery sheath exits
the hemostasis valve.
8. Confirm filter basket expansion by checking in two projections for visibility of the radiopaque markers on the frame of the basket and their
apposition against the vessel wall. Under fluoroscopy, perform a contrast injection to determine that flow is adequate distal to the filter basket
and that the filter basket is in the desired position.
WARNING: The filter basket must be kept distal to the area to be covered by the stent and proximal to the petrous portion of
the carotid artery to avoid excessive forces on the filter basket.
9. Compatible 0.014" guide wire-based interventional devices may now be backloaded onto the guide wire for treatment of the lesion.
CAUTION: Reconfirm the filter basket position prior to deployment of the stent to ensure that there is adequate distance
between the radiopaque proximal bushing marker on the guide wire with filter basket and the distal end of the desired stent
position to avoid stent deployment or entanglement on any part of the filter basket. If it is necessary to reposition the filter
basket further distal to the desired stent position, gently advance the guide wire with filter basket. Under fluoroscopy,
observe movement of the filter basket to the desired position.
Monitoring the Filter Status
WARNING: Maintain continuous flush while removing and reinserting devices on the guide wire. Perform all exchanges slowly to
prevent air embolism or trauma to the artery.
WARNING: Avoid excessive movement of the RX Accunet EPS guide wire and filter basket during catheter device exchanges.
Excessive movement of the deployed basket may cause vessel trauma or spasm.
1. Keep the position of the guide wire with filter basket steady during the intervention.
2. Check the status of the expanded RX Accunet EPS filter basket at regular intervals during the interventional procedure.
3. During the case, keep the following three areas in the field of view at all times:
• Filter basket and / or the proximal bushing marker,
• Lesion area, and
• Radiopaque tip of the guiding catheter / sheath.
Maintaining a view of the tip of the guiding catheter / sheath will minimize the likelihood of the catheter backing out or prolapsing into
the aortic arch.
WARNING: Prolapse of the guiding catheter / sheath into the aortic arch can result in any of the following:
• Movement of an open filter through an undilated lesion;
• Filter-stent entanglement, filter basket detachment and / or proximal movement of the stent; or
• Filter guide wire breakage
EL2069693 (2015-07-31)
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RELEASED RELEASED
Delivery sheath
Torque device
Filter wire
Figure 5 –
Printed on : 01/21/2016
4. Inject contrast through the guiding catheter / sheath and observe flow distal to the filter basket.
WARNING: Allow for and maintain adequate distance between the radiopaque proximal bushing marker on the guide wire
with filter basket and the stent delivery system or other compatible interventional devices to avoid potential entanglement.
WARNING: If excessive debris is collected in the filter basket such that distal perfusion of dye is significantly reduced or no dye
is perfusing past the filter, the RX Accunet EPS may have reached its maximum capacity to contain emboli. Remove and replace
the RX Accunet EPS. Otherwise, it may be difficult to completely recover all embolic debris and the potential for thrombus
release may increase.
Filter Basket Recovery (using the RX Accunet Recovery Catheter or the RX Accunet 2 Recovery Catheter)
1. Remove all interventional devices from the guide wire.
2. Backload the selected, prepared recovery catheter onto the proximal end of the wire and advance the system through the open RHV on the
guiding catheter / sheath.
WARNING: Do not rotate the recovery catheter more than 90 degrees in either direction since this can result in the guide wire
wrapping around the catheter.
WARNING: Use with fixed (passive) hemostatic valves is not recommended.
Note: If using the RX Accunet Recovery Catheter – "Shapeable Tip Design", the distal 3 cm of the RX Accunet Recovery Catheter tip may be
shaped to allow for tip deflection to maneuver around stent struts or in bends. Tip deflection is accomplished by rotating the proximal luer of
the recovery catheter up to 90 degrees in either direction.
3. Under fluoroscopy, carefully advance the selected recovery catheter through the deployed stent.
Note: A variety of techniques can be used to assist passage of the recovery catheter if it has difficulty advancing through the deployed stent.
These techniques are intended to adjust the bias of the guide wire. Some options to aid passage of the recovery catheter are:
• Have the patient rotate her / his neck from side-to-side. This motion may re-orient the carotid artery.
• Change the position of the guiding catheter or guiding sheath. The new position may either re-orient the entry of, or give better support
to, the recovery catheter.
• If using the RX Accunet Recovery Catheter – " Shapeable Tip Design", the tip shape of the recovery catheter can be modified. If one shape
does not pass through the stent, shape the catheter tip in another direction or modify the degree of angulation.
• If stent struts are impeding the advancement of the recovery catheter, post-dilate the stent.
• Insert a guide wire ("buddy wire") to straighten the stented area.
4. If the above techniques are unsuccessful in advancing the recovery catheter through the deployed stent, the alternate recovery catheter should
be prepared and used, after withdrawal of the first recovery catheter; i.e., if the RX Accunet Recovery Catheter will not advance, carefully
withdraw it and advance the RX Accunet 2 Recovery Catheter, or vice versa.
5. Gently advance the selected recovery catheter over the filter basket until the radiopaque tip of the recovery catheter just covers the 4 (four) radi-
opaque wall apposition markers of the filter basket and causes the basket to collapse into the recovery catheter. The filter basket should not be
completely contained within the catheter (see Figure 6).
WARNING: Always keep the open filter basket distal to the deployed stent. Do not attempt to pull an open filter basket through
the stent. Do not attempt to capture the filter basket by pulling it into the recovery catheter if the recovery catheter tip is in
the stent area. Pulling the filter basket into the stent area may lead to stent-filter basket entanglement and / or basket
detachment. If filter basket entanglement or detachment occurs, surgical conversion or collapsing the basket with a second
stent should be considered.
Note: If using the RX Accunet Recovery Catheter, there is a stop (you will feel resistance) when the tip of the recovery catheter is advanced far
enough over the radiopaque wall apposition markers. However, the RX Accunet 2 Recovery Catheter does not have a stop within the tip of the
device. This means that no resistance will be felt if the RX Accunet 2 Recovery Catheter is advanced too far over the RX Accunet Filter Basket. See
Figure 6 for the proper positioning of both the RX Accunet and the RX Accunet 2 Recovery Catheters over the filter basket.
Note: If necessary to facilitate recovery of the filter basket, a simultaneous push-pull maneuver may be used. This may be done when the tip of
the recovery catheter is completely through the stent and at, or beyond, the radiopaque proximal bushing.
Note: Clinical investigators have used other interventional devices, such as compatible guide or balloon catheters, to recover the filter basket in
the instance when difficulty was encountered using the RX Accunet or RX Accunet 2 Recovery Catheters.
Recovery Catheter Tip
PROPER POSITION of Recovery Catheter
for filter basket removal - tip of Recovery
Catheter just covers the radiopaque markers
IMPROPER POSITION - Recovery Catheter
tip advanced beyond radiopaque markers
Recovering the Filter Basket
6. Hold tension on the guide wire and grasp the recovery catheter. Retract the devices together as a single unit with no movement relative to the
catheter and guide wire, ensuring radiographically that the filter basket does not re-deploy.
CAUTION: Care must be used when removing the filter basket through a newly deployed stent to maintain filter basket
integrity and to avoid disrupting the stent geometry.
7. Remove the devices as a unit from the RHV. Ensure that the RHV is fully open when the filter basket is being removed to maintain filter basket
integrity.
Note: If unable to retract the filter basket through the guiding catheter, stabilize the filter basket and recovery catheter at the guiding catheter
tip by tightening down the RHV. Remove the guide wire with filter basket, recovery catheter and guiding catheter as a unit.
Note: If using a Abbott Vascular CoPilot Bleedback Control Valve ensure that the CoPilot is held open while the filter basket is being removed to
maintain filter basket integrity.
WARNING: Discard unused RX Accunet and RX Accunet 2 Recovery Catheters after completing procedure. Failure to discard
unused recovery catheters can result in any or all of the following: the use of a device past its "Use By" date; or the use of an
incorrectly sized RX Accunet Recovery Catheter, which can cause loss of particulates from the filter basket during recovery,
filter-stent entanglement, filter basket detachment and / or proximal movement of stent.
CAUTION: If the RX Accunet EPS is desired for intervention in additional vessels, use a new device.
4 Radiopaque
Markers
Filter Basket
Radiopaque
Markers
Radiopaque
Markers
Figure 6.