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Intended Aortic
Vessel Diameter
19 mm
20 mm
21 mm
21 mm
22 mm
23 mm
24 mm
24 mm
25 mm
26 mm
26 mm
27 mm
28 mm
28 mm
29 mm
29 mm
30 mm
31 mm
Intended Iliac
Vessel Diameter
9 mm
10 mm
11 mm
12 mm
13 mm
14 mm
15 mm
15 mm
16 mm
17 mm
18 mm
18 mm
19 mm
20 mm
21 mm
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 7) 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 8) 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 9)
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 10) 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 11) Continue to inject a
full 20 cc of flushing solution through the device. Discontinue injection
and close stopcock on connecting tube.
9.5.1 Proximal Body Graft Diameter Sizing
Main Body
Diameter
24 mm
24 mm
24 mm
26 mm
26 mm
28 mm
28 mm
30 mm
30 mm
30 mm
32 mm
32 mm
32 mm
34 mm
34 mm
36 mm
36 mm
36 mm
9.5.2 Distal Ipsilateral Graft Diameter Sizing
Ipsilateral
Fenestrated Leg
12 mm
12 mm
12 mm
16 mm
16 mm
16 mm
16 mm
20 mm
20 mm
20 mm
20 mm
24 mm
24 mm
24 mm
24 mm
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 9)
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 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:
• Wire guides – standard .035 inch (0.89 mm) diameter, 145 cm long,
J tip or Bentson Wire Guide
• Appropriate size sheaths (e.g., 6 French (2.0 mm I.D.) or 8 French
(2.7 mm I.D.))
• Flush catheter (often radiopaque sizing catheters – e.g., Centimeter
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.
10.1.4 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 15a)
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.
• A marker formation of indicates an anterior position of the
anterior markers. (Figure 15a, Illustration A)
• A marker formation of indicates a posterior position of the
anterior markers. (Figure 15a, Illustration B)
NOTE: Angiography should be performed as needed throughout
deployment, to con rm correct placement of the graft.
30
Introduction Sheath
French Size
(I.D. / O.D.)
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
22 Fr
7.3 mm / 8.5 mm
22 Fr
7.3 mm / 8.5 mm
22 Fr
7.3 mm / 8.5 mm
Introduction Sheath
French Size
(I.D. / O.D.)
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
20 Fr
6.7 mm / 7.7 mm
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