COOK Medical Zenith Flex, Instructions For Use Manual

Page: 31 / 220

31
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.
11.1.2 Contralateral Iliac Leg 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. 8) 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. 6) Continue to
inject a full 20 cc of flushing solution through the device. Discontinue
injection and close stopcock on connecting tube.
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. 7)
NOTE: When flushing system, elevate distal end of system to facilitate removal
of air.
11.1.3 Ipsilateral Iliac Leg Preparation/Flush
Follow the previous Section 11.1.2, Contralateral Iliac Leg Preparation/
Flush instructions to ensure proper flushing of the ipsilateral iliac leg graft.
11.1.4 Vascular Access and Angiography
1. Puncture the selected common femoral arteries using standard technique
with an 18 or 19 UT gage arterial needle. Upon vessel entry, insert:
• Wire guides — standard .035 inch diameter, 145 cm long, J tip
or Bentson Wire Guide
• Appropriate size sheaths (e.g., 6 or 8 French)
• 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 fluoroscope angulation is used with an angulated neck, it may be
necessary to perform angiograms using various projections.
11.1.5 Main Body Placement
1. Ensure the delivery system has been flushed with heparinized 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 (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.
4. Before insertion, position main body delivery system on patient’s
abdomen under fluoroscopy to determine the orientation of the
contralateral limb radiopaque marker. The sidearm of the hemostatic
valve may serve as an external reference to the contralateral limb
radiopaque marker.
5. Insert main body delivery system over the wire, into the femoral artery
with attention to sidearm reference.
CAUTION: Maintain wire guide position during delivery system insertion.
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).
6. Advance delivery system until the four gold radiopaque markers (which
are positioned 2 mm from the most proximal segment of the graft
material) (Fig. 9, Illustration 1) are just inferior to the most inferior renal
orifice.
7. Verify position of wire guide in the thoracic aorta. Ensure the graft system
is oriented such that the contralateral limb is positioned above and
anterior to the origin of the contralateral iliac. If the contralateral limb
radiopaque marker is not properly aligned, rotate the entire system until it
is correctly positioned halfway between a lateral and an anterior position
on the contralateral side.
• A marker formation of a ✓ indicates an anterior position of
the short (contralateral) limb. (Fig. 9, Illustration 4)
• A marker formation of a
✓
indicates a posterior position of the
short (contralateral) limb. (Fig. 9, Illustration 5)
• A marker formation of a | indicates a lateral position of the
short (contralateral) limb. (Fig. 9, Illustration 6)
10.5 Device Sizing Guidelines
The choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter. Undersizing or oversizing may
result in incomplete sealing or compromised flow.
Table 10.5.1 Main Body Graft Sizing Guide*
Intended Aortic
Vessel Diameter 1,2 (mm)
Main Body
Diameter 3 (mm)
Overall Length to Contralateral Limb/
Overall Length to Ipsilateral Limb
(mm)
Introducer
Sheath (Fr)
18-19 22 82/112, 96/126, 111/141, 125/155, 140/170 18
20-21 24 82/112, 96/126, 111/141, 125/155, 140/170 18
22 26 82/112, 96/126, 111/141, 125/155, 140/170 18
23-24 28 82/112, 96/126, 111/141, 125/155, 140/170 20
25-26 30 82/112, 96/126, 111/141, 125/155, 140/170 20
27-28 32 82/112, 96/126, 111/141, 125/155, 140/170 20
29-32 36 95/125, 113/143, 131/161, 149/179 22
1 Maximum diameter along the proximal fixation site.
2
Round measured aortic diameter to nearest mm.
3 Additional considerations may affect choice of diameter.
*All dimensions are nominal.
Table 10.5.2 Iliac Leg Graft Sizing Guide*
Intended Iliac
Vessel Diameter
1,2
(mm)
Iliac Leg
Diameter
3
(mm)
Iliac Leg
Working Length
4
(mm)
Introducer
Sheath (Fr)
<8 8 37, 54, 71, 88, 105, 122 14
8-9 10 37, 54, 71, 88, 105, 122 14
10-11 12 39, 56, 73, 90, 107, 124 16
12-13 14 39, 56, 73, 90, 107, 124 16
14-15 16 39, 56, 73, 90 16
16-17 18 39, 56, 73, 90 16
18 20 39, 56, 73, 90 16
19 22 39, 56, 73, 90 16
20 24 39, 56, 73, 90 16
1 Maximum diameter along the distal fixation site.
2
Round measured iliac diameter to nearest mm.
3 Additional considerations may affect choice of diameter.
4
Overall leg length = working 22 mm docking stent.
*All dimensions are nominal.
11 DIRECTIONS FOR USE
Anatomical Requirements
• Iliofemoral access vessel size and morphology (minimal thrombus, calcium
and/or tortuosity) should be compatible with vascular access techniques
and accessories. Arterial conduit techniques may be required.
• Proximal aortic neck lengths should be a minimum of 15 mm with a
diameter measured outer wall to outer wall of 18 – 32 mm.
• Iliac artery distal fixation site should be greater than 10 mm in length and
7.5 – 20 mm in diameter (measured outer wall to outer wall).
Prior to use of the Zenith Flex AAA Endovascular Graft with the Z-Trak
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.
General Use Information
Standard techniques for placement of arterial access sheaths, guiding
catheters, angiographic catheters and wire guides should be employed during
use of the Zenith Flex AAA Endovascular Graft with the Z-Trak Introduction
System. The Zenith Flex AAA Endovascular Graft with the Z-Trak Introduction
System is compatible with .035 inch diameter wire guides.
Endovascular stent grafting is a surgical procedure, and blood loss from
various causes may occur, infrequently requiring intervention (including
transfusion) to prevent adverse outcomes. It is important to monitor blood
loss from the hemostatic valve throughout the procedure, but is specifically
relevant during and after manipulation of the gray positioner. After the gray
positioner has been removed, if blood loss is excessive, consider placing an
uninflated molding balloon or an introduction system dilator within the valve,
restricting flow.
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 iliac arteries.
3. Quality of the aortic neck.
4. Diameters of infrarenal aortic neck and distal iliac arteries.
5. Distance from renal arteries to the aortic bifurcation.
6. Length from the aortic bifurcation to the 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.
Patient Preparation
1. Refer to institutional protocols relating to anesthesia, anticoagulation and
monitoring of vital signs.
2. Position patient on imaging table allowing fluoroscopic visualization 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.
11.1 Bifurcated System (Figs. 2 and 3)
11.1.1 Bifurcated Main Body 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 hemostatic valve. (Fig. 5) 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. 6) Continue to inject
a full 20 cc of flushing solution through the device. Discontinue injection
and close stopcock on connecting tube.
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. 7)
NOTE: When flushing system, elevate distal end of system to facilitate removal
of air.
31