Main Body Extension Molding Balloon Insertion; Iliac Legs And Iliac Leg Extensions; Iliac Leg Extension Preparation/Flush; Iliac Leg Extension Placement And Deployment - COOK Medical Zenith Instrucciones De Uso

11 . Re-check the position of the wire guide . Leave sheath and wire guide in
place .

Main Body Extension Molding Balloon Insertion

NOTE: For information on the use of recommended products (listed on
page 22) refer to the individual product's instructions for use .
1 . Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline .
• Remove all air from balloon .
2 . In preparation for the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise .
3 . Advance the molding balloon over the wire guide and through the
hemostatic valve of the main body extension introduction system to the
level of the main body extension .
CAUTION: Do not inflate balloon in vessel outside of graft.
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure, by turning it clockwise .
5 . Expand the molding balloon within the most proximal segment of the
main body extension and then the most distal segment of the main
body extension using diluted contrast media (as recommended by the
manufacturer) . (Fig. 17)
CAUTION: Confirm complete deflation of balloon prior to repositioning.
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
the molding balloon.
6 . Completely deflate and remove molding balloon, replace it with an
angiographic catheter and perform completion angiograms .
7 . If no other endovascular maneuvers are necessary, remove any sheaths,
wires and catheters . Repair vessels and close in standard surgical fashion .

11.3 Iliac Legs and Iliac Leg Extensions

The iliac leg extensions (Fig. 4) are used for extending the distal iliac legs
and/or bridging an in situ endovascular graft . If an iliac leg extension is not
available, an iliac leg (Fig. 3) can be used . If using an iliac leg/iliac leg
extension as part of primary repair, the iliac leg/iliac leg extension delivery
system may be introduced through an existing in situ 18, 20 or 22 French
introduction system sheath .

Iliac Leg Extension Preparation/Flush

1 . Remove the gray-hubbed shipping stylet (from the inner cannula) and
dilator tip protector (from the dilator tip) . Remove Peel-Away sheath from
the back of the hemostatic valve . (Fig. 18) Elevate distal tip of system and
flush through the stopcock on the hemostatic valve until fluid emerges
from the flushing groove near the tip of the introducer sheath . (Fig. 8)
Continue to inject a full 20 cc of flushing solution through the device .
Discontinue injection and close stopcock .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach syringe with heparinized saline to the hub on the inner cannula .
Flush until fluid exits the dilator tip . (Fig. 9)
NOTE: When flushing system, elevate distal end of system to facilitate
removal of air .
3 . Soak sterile gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate the hydrophilic coating . Hydrate both sheath
and dilator liberally .

Iliac Leg Extension Placement and Deployment

1 . Replace J tip wire guide with stiff wire guide (LES), .035 inch, 260 cm long,
and advance through catheter and up to the thoracic aorta . Remove flush
catheter and sheath . Maintain wire guide position .
2 . Introduce the iliac leg extension delivery system into the artery .
NOTE: If the Zenith Flex AAA Endovascular Graft main body delivery system is
being utilized to introduce the iliac leg extension, ensure the Captor
Hemostatic Valve is in the open position prior to introduction and
deployment of the iliac leg extension .
3 . Advance slowly until the iliac leg extension is at the site of the required
intervention . (Fig. 19) Ensure that a proper placement is achieved . Verify
appropriate stent graft overlap to ensure proper sealing and resistance to
migration .
4 . Verify placement with angiography to ensure the internal iliacs will remain
patent .
NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath is
turned to the open position . (Fig. 11)
5 . Use the gripper to stabilize the gray positioner while withdrawing the
sheath . (Figs. 12 and 20)
6 . Continue to deploy the device until the distal stent is uncovered . (Fig. 21)
Stop withdrawing the sheath .
7 . Withdraw the tapered tip of the introducer back through the iliac leg
extension graft and sheath while maintaining wire guide position . Ensure
the endovascular graft is not displaced during withdrawal of delivery
system .

Iliac Leg Extension Molding Balloon Insertion

NOTE: For information on the use of recommended products (listed on
page 22) refer to the individual product's instructions for use .
1 . Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline .
• Remove all air from balloon .
2 . In preparation for the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise .
3 . Advance the molding balloon over the wire guide and through the
hemostatic valve to the most proximal segment of the iliac leg extension .
CAUTION: Do not inflate balloon in vessel outside of graft.
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure, by turning it clockwise .
5 . Expand the molding balloon within the most proximal segment and then
the most distal segment of the iliac leg extension using diluted contrast
media (as recommended by the manufacturer) . (Fig. 22)
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
the molding balloon.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
6 . Completely deflate and remove molding balloon, replace it with an
angiographic catheter and perform completion angiograms .
7 . If no other endovascular maneuvers are necessary, remove any sheaths,
wires and catheters . Repair vessels and close in standard surgical fashion .

11.4 Converter

Converters can be used to convert a bifurcated graft into an aorto-uniiliac
graft, if necessary (e .g ., cases of Type III endoleak, limb occlusion or
unattainable contralateral limb cannulation) . (Fig. 5)

Converter Preparation/Flush

1 . Remove gray-hubbed shipping stylet (from the inner cannula) and dilator
tip protector (from the dilator tip) . Remove Peel-Away sheath from back
of the hemostatic valve . (Fig. 18) Elevate distal tip of system and flush
through the stopcock on the hemostatic valve until fluid emerges from
the sideport near the tip of the introducer sheath . (Fig. 8) Continue to
inject a full 20 cc of flushing solution through the device . Discontinue
injection and close stopcock .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach syringe with heparinized saline to the hub on the inner cannula .
Flush until fluid exits the dilator tip . (Fig. 9)
NOTE: When flushing system, elevate distal end of system to facilitate
removal of air .
3 . Soak sterile gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate hydrophilic coating . Hydrate both sheath
and dilator liberally .

Converter Placement and Deployment

1 . Replace J tip wire guide with stiff wire guide (LES), .035 inch, 260 cm long,
and advance through catheter and up to the thoracic aorta . Remove flush
catheter and sheath . Maintain wire guide position .
2 . Introduce the converter delivery system into the artery .
CAUTION: The converter delivery system cannot be introduced through a
main body or iliac leg introducer sheath.
3 . Advance slowly until the converter is at the site of the required
intervention . (Fig. 23) Verify appropriate stent graft overlap to ensure
proper sealing and resistance to migration . The proximal two stents
should be positioned in the main body graft, and the distal two stents
should be positioned in the ipsilateral leg .
NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath is
turned to the open position .
4 . Use the gripper to stabilize the gray postioner while withdrawing the
sheath . (Figs. 12 and 24)
5 . Continue to deploy the device until the distal stent is uncovered . (Fig. 25)
6 . Withdraw the tapered tip of the introducer back through the converter
graft and sheath while maintaining wire guide position . Ensure the
endovascular graft is not displaced during withdrawal of delivery system .

Converter Molding Balloon Insertion

NOTE: For information on the use of recommended products (listed on page
22) refer to the individual product's instructions for use .
1 . Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline .
• Remove all air from balloon .
2 . In preparation for the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise .
3 . Advance the molding balloon over the wire guide and through the
hemostatic valve to the most proximal segment of the converter .
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise .
CAUTION: Do not inflate balloon in vessel outside of graft.
5 . Expand the molding balloon within the most proximal segment and then
the most distal segment of the converter using diluted contrast media (as
recommended by the manufacturer) . (Fig. 26)
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
the molding balloon.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
6 . Completely deflate and remove molding balloon, replace it with an
angiographic catheter and perform completion angiograms .
7 . If no other endovascular maneuvers are necessary, remove any sheaths,
wires and catheters . Repair vessels and close in standard surgical fashion .

11.5 Iliac Plug

The Iliac Plug (Fig. 6) is used to occlude an iliac artery, typically in conjunction
with a femoral-to-femoral crossover procedure .

Iliac Plug Preparation/Flush

1 . Remove the gray-hubbed shipping stylet (from the inner cannula) .
Remove Peel-Away sheath from the back of the hemostatic valve . (Fig. 27)
Elevate distal tip of system and flush through the stopcock on the
hemostatic valve until fluid exits the dilator tip . (Fig. 28) Continue to inject
a full 20 cc of flushing solution through the device . Discontinue injection
and close stopcock .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach syringe with heparinized saline to the hub on the inner cannula .
Flush until fluid exits the dilator tip . (Fig. 29)
NOTE: When flushing system, elevate distal end of system to facilitate
removal of air .
3 . Soak sterile gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate hydrophilic coating . Hydrate both sheath
and dilator liberally .

Iliac Plug Placement

1 . Perform angiography to determine proper iliac plug placement (below
aortic bifurcation and above iliac bifurcation) .
2 . Replace J wire with stiff wire guide (LES), .035 inch, at least 145 cm long,
and advance through catheter and above the aortic bifurcation, being
careful not to disturb any previously placed graft .
3 . Insert the delivery system over the wire into the femoral artery . (Fig. 30)
4 . Advance the delivery system to the intended position in the common iliac
artery .
5 . Verify placement with angiography of the iliac plug relative to the internal
iliac artery .
CAUTION: Maintain wire guide position during delivery system insertion.
NOTE: The iliac plug is tethered to the gray positioner, which allows the iliac
plug to be repositioned within the vessel .

Iliac Plug Deployment

NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath is
turned to the open position .
1 . Verify position of wire guide in the iliac artery . Deploy the iliac plug
by withdrawing the sheath while stabilizing the gray positioner of the
delivery system with the gripper . Withdraw the sheath until the iliac plug
is uncovered . (Figs. 31 and 32) Stop withdrawing sheath .
2 . Remove the safety lock from the trigger-wire release mechanism .
Withdraw and remove the trigger-wire by sliding the trigger-wire release
mechanism off the handle, and then remove via its slot over the inner
cannula . (Fig. 33)
3 . Perform angiography to verify position of the iliac plug with respect to the
internal iliac artery .
4 . Withdraw the wire guide while maintaining position of the gray positioner .
Ensure the endovascular graft is not displaced during withdrawal of wire
guide .
5 . Slowly withdraw gray positioner . Ensure the endovascular graft is not
displaced during withdrawal of gray positioner .

Iliac Plug Molding Balloon Insertion

NOTE: The expandable length of the Zenith AAA Iliac Plug is 30 mm . To avoid
inflation of molding balloon outside the distal aspect of the plug, the balloon
should fit within the expandable length of the plug .
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