19
polymer fill port should move away from stent graft.
WARNING: If resistance is encountered during catheter
withdrawal, STOP. Identify cause of resistance and resolve prior
to continuing withdrawal. Catheter rotation may be sufficient to
overcome resistance.
4
While maintaining guidewire position, use catheter handle to retract
nosecone to tip of delivery system outer sheath.
5
Remove the aortic body delivery system.
Ipsilateral Limb Insertion and Deployment
1
Follow the appropriate procedural steps for ipsilateral limb deployment
as previously described in Contralateral Limb Insertion and
Deployment.
Deployment Completion
1
Verify aneurysm exclusion. Perform angiography from proximal landing
site to distal landing sites.
2
Although not required as part of the implant procedure, angioplasty
balloons of appropriate sizes (diameter equivalent to the vessel size)
may be used to improve aneurysm exclusion or to improve the stent
graft lumen.
WARNING: It is important to accurately size the balloons and
not over-inflate within the stent graft. Carefully follow the
balloon manufacturer’s inflation parameters described in the
product labeling.
•
Prepare balloon catheters and other adjunctive devices to be
used according to the manufacturer’s Instructions For Use.
•
Iliac limb/ aortic body junction: The junction may be ballooned
using a 12 mm non-compliant balloon, inflated to no more than 5
atm. The “kissing balloon” technique may be utilized at this
location.
•
Distal iliac: The area may be ballooned using a non-compliant
balloon the same diameter as the distal iliac diameter.
WARNING: Do not balloon the iliac limb/ aortic body junction or
the distal iliac with a compliant balloon.
•
After removal of the angiographic catheter (if present), the proximal
aortic body may be ballooned before delivery system removal with a
compliant balloon of the same diameter as the proximal aortic
diameter. A noncompliant balloon may be used in the aortic body
only after the delivery system is removed.
CAUTION: It is not recommended to balloon prior to 15 minutes after
completion of the final polymer mix. Ballooning prior to 15 minutes
could damage the sealing rings.
3
If no other interventions are required and aneurysm exclusion has
been verified, remove the angiographic catheter and maintain
guidewire position(s). If extension of the iliac is required, proceed
with the Iliac Extension Insertion and Deployment steps below.
4
Remove guidewires and introducer sheaths. Close vascular access.
