Bard COVERA PLUS Instructions For Use Manual page 6

NOTE:
Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non-
diseased segment of the vessel. In the case of overlapping devices, at least 10 mm of overlap between devices is recommended.
For covered stent placements in the proximal cephalic arch, select the length such that the ostial lesion is fully covered and that
the proximal covered stent end does not compromise the flow in the axillary/subclavian vein. Ensure that the covered stent end
extends at least 10 mm beyond the arch curvature into the straight distal cephalic vein segment.
PRECAUTION:
For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac
bifurcation. Make sure that the proximal covered stent end is positioned in a straight section of the vessel during deployment
(Figure 6).
WARNING:
DO NOT track and deploy the 9F endovascular system across the aorto-iliac bifurcation in crossover fashion since this may result
in failure to deploy the covered stent.
Figure 6
Covered Stent Deployment
9. Prior to covered stent deployment, unlock the red safety lock (Figure 7) by pressing it down and pulling it back towards the
end of the grip from the locked position into the unlocked position
retracted and that the symbol for the unlocked position
Figure 7
. Ensure that the red safety lock is completely
is fully visible.
10. With your free hand, maintain a stationary hold on the white stability sheath during covered stent deployment and adjust
for placement accuracy if necessary (Figure 8). Hold the white stability sheath as close as possible to the introducer without
touching the dark brown moving catheter of the distal catheter assembly. Maintain the remainder of the white stability
sheath (segment between left and right hand on illustration) relaxed and avoid tension.
Figure 8
PRECAUTION:
During device placements in cross-over technique, maintain the proximal covered stent end in a straight position throughout
deployment.
IMPORTANT:
Do not touch the distal catheter assembly (i.e. the dark brown catheter segment) during covered stent
deployment since this may interfere with covered stent deployment and may lead to misplacement (Figure 9).
Figure 9
11. Slowly and carefully activate the stent release mechanism by rotating backwards the large wheel on the top of the handle.
NOTE: For accurate placement, subtle repositioning may be performed during initial wheel activation while
the covered stent is still compressed in the catheter.
After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.
Ensure the covered stent has wall apposition before completing deployment (Figure 10).
6