Instructions For Use; General Use Information; Pre-Implant Determinants; Patient Preparation - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

10 INSTRUCTIONS FOR USE

General Use Information

Prior to use of the Zenith Fenestrated AAA Endovascular Graft with the
H&L-B One-Shot Introduction System, review this Suggested Instructions
for Use booklet. The following instructions embody a basic guideline for
device placement. Variations in the following procedures may be necessary.
These instructions are intended to help guide the physician and do not take
the place of physician judgment.

Pre-Implant Determinants

Verify from pre-implant planning that the correct device has been selected.
Determinants include:
1. Femoral artery selection for introduction of the main body system, (i.e.,
define respective contralateral and ipsilateral iliac arteries).
2. Angulation of aortic neck, aneurysm and iliacs.
3. Quality of the aortic neck.
4. Diameters of infrarenal aortic neck and distal iliac vessels.
5. Distance from renal arteries to the aortic bifurcation.
6. Distance from the renal arteries to the hypogastric (internal iliac)
arteries/attachment site(s).
7. Aneurysm(s) extending into the iliac arteries may require special
consideration in selecting a suitable graft/artery interface site.
8. Consider the degree of vascular calcification.
NOTE: Each respective vessel diameter and length (aorta, ipsilateral iliac
and contralateral iliac) provides the necessary criteria for choosing the
appropriate endovascular graft.

Patient Preparation

1. Refer to institutional protocols relating to anesthesia, anticoagulation
and monitoring of vital signs.
2. Position patient on imaging table allowing fluoroscopic visualisation
from the aortic arch to the femoral bifurcations.
3. Expose both common femoral arteries using standard surgical
technique.
4. Establish adequate proximal and distal vascular control of both femoral
vessels.

10.1 Fenestrated System

10.1.1 Bifurcated Main Body Preparation/Flush

1. Remove black-hubbed shipping stylet (from the inner cannula),
cannula protector tube (from the inner cannula) and dilator tip
protector (from the dilator tip). Remove Peel-Away® sheath from back
of the hemostatic valve. (Figure 8) Elevate distal tip of system and
flush through the stopcock on the hemostatic valve until fluid emerges
from the flushing groove in the tip. (Figure 9) Continue to inject a full
20 cc of flushing solution through the device. Discontinue injection
and close stopcock on connecting tube.
NOTE: Graft ushing solution of Heparinised saline is always used.
2. Attach syringe with normal Heparinised saline to the hub on the inner
cannula. Flush until fluid exits the distal tip. (Figure 10)
NOTE: When ushing system, elevate distal end of system to facilitate
removal of air.
3. Soak 4x4 gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate the hydrophilic coating. Hydrate both
sheath and dilator tip liberally.

10.1.2 Distal Bifurcated Body Graft Preparation/Flush

1. Remove black-hubbed shipping stylet (from the inner cannula),
cannula protector tube (from the inner cannula) and dilator tip
protector (from the dilator tip). Remove Peel-Away sheath from back of
the hemostatic valve. (Figure 11) Elevate distal tip of system and flush
through the stopcock on the hemostatic valve until fluid emerges from
the flushing groove in the tip. (Figure 12) Continue to inject a full 20
cc of flushing solution through the device. Discontinue injection and
close stopcock on connecting tube.
NOTE: Graft ushing solution of Heparinised saline is always used.
2. Attach syringe with normal Heparinised saline to the hub on the inner
cannula. Flush until fluid exits the distal tip. (Figure 10)
NOTE: When ushing system, elevate distal end of system to facilitate
removal of air.
3. Soak 4x4 gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate the hydrophilic coating. Hydrate both
sheath and dilator tip liberally.

10.1.3 Iliac Leg (Contralateral) Preparation/Flush

1. Remove black-hubbed inner stylet (from the inner cannula), cannula
protector tube (from the inner cannula) and dilator tip protector (from
the dilator tip). Remove Peel-Away sheath from back of the hemostatic
valve. (Figure 13) 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 introduction sheath. (Figure 14) Continue to inject a
full 20 cc of flushing solution through the device. Discontinue injection
and close stopcock on connecting tube.
NOTE: Graft ushing solution of Heparinised saline is always used.
2. Attach syringe with Heparinised saline to the hub on the distal inner
cannula. Flush until fluid exits the distal dilator tip. (Figure 15)
NOTE: When ushing system, elevate distal end of system to facilitate
removal of air.

10.1.4 Vascular Access and Angiography

1. Puncture the selected common femoral arteries using standard
technique with an 18 or 19UT gage arterial needle. Upon vessel entry,
insert:
J tip or Bentson Wire Guide
(2.7 mm I.D.))
Sizing Catheter or straight flush catheter)
2. Perform angiography to identify level(s) of renals, aortic bifurcation
and iliac bifurcations.
NOTE: If uoroscope angulation is used with an angulated neck it may be
necessary to perform angiograms using various projections.
NOTE: A previous planning exercise will have determined which side will
be used to introduce the proximal and distal bodies.

10.1.5 Proximal Body Placement

CAUTION: Verify that the predetermined access site is chosen for the
introduction and placement of the proximal body.
1. Ensure the delivery system has been flushed with Heparinised saline
and that all air is removed from the system.
2. Give systemic heparin and check flushing solutions. Flush after each
catheter and/or wire guide exchange.
NOTE: Monitor the patient's coagulation status throughout the procedure.
3. On ipsilateral side, replace J wire with stiff wire guide (AUS or LES) .
035 inch (0.89 mm), 260 cm long and advance through catheter and
up to the thoracic aorta. Remove flush catheter and sheath. Maintain
wire guide position.
NOTE: A straight angiographic catheter may be inserted up the
contralateral side to aid in placement of graft.
4. Before insertion, position proximal body delivery system on patient's
abdomen under fluoroscopy to assist with orientation and positioning.
Rotate to a position where the anterior markers are situated in the
most anterior (12:00 o'clock) position. The sidearm of the hemostatic
valve may serve as an external reference to the fenestration(s) and/or
scallop(s), anterior and posterior markers and body side markers.
CAUTION: Maintain wire guide position during delivery system
insertions.
CAUTION: To avoid any twist in the endovascular graft, during any
rotation of the delivery system, be careful to rotate all of the
components of the system together (from outer sheath to inner
cannula).
5. Advance the delivery system until the radiopaque markers indicating
the fenestration(s) and/or scallop(s) are at the level of the appropriate
arteries. Check that the distal end of the graft is in a satisfactory position
above the aortic bifurcation and that the anterior and posterior markers
indicate that the graft is in satisfactory orientation. (Figure 16a)
6. The 'tick' marker can be used to assist with orientation of the graft
during deployment and prevent 180-degree mis-orientation of the
graft.
 indicates an anterior position of the
anterior markers. (Figure 16a, Illustration A)
 indicates a posterior position of the
anterior markers. (Figure 16a, Illustration B)
NOTE: Angiography should be performed as needed throughout
deployment, to con rm correct placement of the graft.
7. Verify position of the wire guide in the thoracic aorta. Ensure that
fenestration(s) and/or scallops are at the level of the appropriate arteries
and the anterior markers are in the most anterior (12:00 o'clock) position.
NOTE: The vertical anterior markers, and the horizontal posterior markers
should form a cross, on the uoroscopic image, when correctly oriented.
(Figure 16b)
NOTE: The fenestration/scallop markers should be in close apposition to
the appropriate side branch vessels.
NOTE: Ensure the Captor Hemostatic Valve on the Flexor introducer sheath
is turned to the open position. (Figure 17)
Clear identi cation of fenestration position(s) may not be possible until the
graft has been fully unsheathed.
8. Stabilise the grey positioner (the shaft of the delivery system) while
withdrawing the sheath. Deploy the first two (2) covered stents by
withdrawing the sheath while monitoring device location.
9. Perform angiography, and adjust graft placement as necessary.
Continue to withdraw the sheath making positional adjustments as
necessary.
NOTE: Techniques to ensure that the fenestration(s) and/or scallop(s) will
accurately align with their respective vessels will vary, and will depend
upon vessel anatomy, graft design, and physician preferences.
10. Proceed with deployment until the graft has been fully unsheathed.
(Figure 18)
11. When a satisfactory graft position has been achieved, withdraw the
angiographic catheter and wire guide, then exchange to selective
wire guide/selective catheter to below the level of the proximal body.
Cannulate the partially deployed proximal main body.
NOTE: If a small fenestration is being utilised, care should be taken to
properly align the fenestration with the respective vessel.
12. Utilising contralateral access sheath and wire guide, cannulate and
advance a guiding catheter into each small fenestration and its respective
vessel. (Figure 19)
NOTE: Non-compliant angioplasty balloons may be used as an alternative
to guiding catheters.
NOTE: Cannulation of the scallop and its respective vessel may also be
achieved using similar techniques.
NOTE: It is not recommended to use balloons or guiding catheters to guide
nal placement of large fenestrations as stent struts across fenestration
may interfere.
CAUTION: Before release of the diameter reducing ties, verify that the
position of the ipsilateral access wire extends just distal to the aortic
arch.
CAUTION: During proximal trigger-wire removal, top cap
advancement, and subsequent suprarenal stent deployment, verify
that the position of the main body wire guide extends just distal to the
aortic arch and that support of the system is maximized.
13. Verify proper position of proximal body. Remove the safety lock from
the gold trigger-wire release mechanism. Withdraw and remove the
trigger-wire to release diameter reducing ties by sliding the gold
trigger-wire release mechanism off the handle and then remove via its
slot over the inner cannula. (Figure 20)
NOTE: At this point, the proximal main body graft should be fully expanded
with the proximal bare stent contained within the top cap.
14. Remove the safety lock from the black trigger-wire release mechanism.
Under fluoroscopy, withdraw and remove the trigger-wire to unlock
the suprarenal stent from the top cap by sliding the black trigger-wire
release mechanism off the handle and then remove via its slot over the
inner cannula. (Figure 21)
NOTE: If resistance is felt or system bowing is noticed, the trigger-wire is
under tension. Excessive force may cause the graft position to be altered. If
excessive resistance or delivery system movement is noted, stop and assess
the situation.
If unable to remove the black trigger-wire release mechanism from the top
cap, perform the following steps under uoroscopy:
a. Remove tension on the trigger-wire by loosening the pin vise and slightly
pulling the inner cannula to move the top cap down over the suprarenal
stent. Avoid compressing the Zenith Fenestrated proximal body.
b. Retighten the pin vise.
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