Directions For Use; Anatomical Requirements; General Use Information; Pre-Implant Determinants - COOK Medical Zenith Instrucciones De Uso

Table 10.5.3 Spiral-Z AAA Iliac Leg Graft Sizing Guide*
Intended Intended
Iliac Vessel Iliac Vessel
Diameter 1,2 Diameter 3
(mm) (mm)
≤8 9
9 11
10-12 13
13-15 16
16-18 20
19-20 24
1
Maximum diameter along the proximal fixation site .
2
Round measured iliac diameter to nearest mm .
3
Additional considerations may affect choice of diameter .
4 Overall leg length = working length + 22 mm docking stent .
*All dimensions are nominal .
Table 10.5.4 Iliac Leg Extension Graft Diameter Sizing Guide*
Intended Iliac Leg
Iliac Vessel Extension
Diameter 1,2 Diameter
(mm) (mm)
<8 8
8-9 10
10-11 12
12-13 14
14-15 16
16-17 18
18 20
19 22
20 24
1
Maximum diameter along the distal fixation site .
2
Round measured iliac diameter to nearest mm .
3
Additional considerations may affect choice of diameter .
*All dimensions are nominal .
Table 10.5.5 Converter Graft Diameter Sizing Guide*
Main Body Converter
Diameter Diameter
(mm) (mm)
22 24
24 24
26 28
28 28
30 32
32 32
36 36
1
Additional considerations may affect choice of diameter .
*All dimensions are nominal .
Table 10.5.6 Zenith Iliac Plug Graft Diameter Sizing Guide*
Intended
Iliac Plug
Iliac Vessel
Diameter
Diameter 1,2
(mm)
(mm)
8-10 14
11-12 16
13-16 20
17-20 24
1
Maximum diameter along the distal fixation site .
2
Round iliac diameter to nearest mm .
3
Additional considerations may affect choice of diameter .
*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 .
• For use of the main body extension, proximal aortic necks 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 AAA Ancillary Components 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 judgement .

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 AAA Ancillary Components with the Z-Trak
Introduction System .
• Endovascular stent grafting is a surgical procedure, and blood loss from
various causes may occur, infrequently requiring intervention (including
Iliac Leg Working Introducer
Length 4 (mm) Sheath (Fr)
39, 56, 74, 90, 107,122
39, 56, 74, 90, 107,122
39, 56, 74, 90, 107,122
39, 56, 74, 90
39, 56, 74, 90
39, 56, 74, 90
Iliac Leg Introducer
Extension Length
3
(mm)
55
55
55
55
55
55
55
55
55
Converter Introducer
1 Length
(mm)
80
80
80
80
80
80
82
Iliac Plug Introducer
3 Length
(mm)
30
30
30
30
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

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Verify from pre-implant planning that the correct device has been selected .
Determinants include:
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1 . Femoral artery selection for introduction of the delivery system .
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2 . Angulation of aortic neck, aneurysm and iliac arteries .
3 . Quality of the aortic neck, if main body extension is used .
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4 . Diameters of infrarenal aortic neck and distal iliac arteries .
5 . Distance from renal arteries to the bifurcation of a previously placed
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bifurcated graft, if main body extension is to be used .
6 . Length from the bifurcation of a previously placed bifurcated graft to the
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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 . Degree of vascular calcification .

Patient Preparation

If using Zenith AAA Ancillary Components as part of a secondary procedure:
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 selected common femoral artery using standard surgical technique .
Sheath
When a femoral-to-femoral crossover will be required as part of the
(Fr)
procedure, both common femoral arteries should be exposed .
4 . Establish adequate proximal and distal vascular control of selected femoral
vessel .
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NOTE: The Zenith AAA Ancillary Components are designed to be introduced
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through an exposed common femoral artery on the selected side of
introduction . Angiography at the implant site may be achieved by the use of a
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straight angiographic catheter inserted from the contralateral side, either by
surgical exposure or percutaneous approach .
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5 . Puncture the selected common femoral arteries using standard technique
with an 18 or 19 UT gage arterial needle . Upon vessel entry, insert:
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• Wire guides – standard .035 inch diameter, 145 cm long, J tip or Bentson
Wire Guide
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• Appropriate size sheaths (e .g ., 6 or 8 French)
• Flush catheter (often radiopaque sizing catheters – e .g ., Centimeter Siz-
16
ing Catheter or straight flush catheter)
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6 . Perform angiography to identify level(s) of renals, bifurcation of the
previously placed bifurcated graft and iliac bifurcations .
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NOTE: If fluoroscope angulation is used with an angulated neck, it may be
necessary to perform angiograms using various projections .

11.1 Ancillary Components General Use Information

Inaccuracies in device size selection or placement, changes or anomalies in
patient anatomy or procedural complications can require placement of
additional endovascular grafts, extensions, iliac plugs and converters .
Regardless of the device placed, the basic procedure(s) will be similar to the
maneuvers required for Zenith AAA stent grafts . It is vital to maintain wire
guide access .
Standard techniques for placement of arterial access sheaths, guiding
Sheath
catheters, angiographic catheters and wire guides should be employed during
(Fr)
use of the Zenith AAA Ancillary Components . The Zenith AAA Ancillary
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Components with the Z-Trak Introduction System are compatible with
.035 inch diameter wire guides .
18
If necessary to increase hemostasis, an uninflated molding balloon or an
introduction system dilator may be placed within the hemostatic valve .
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11.2 Main Body Extensions

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Main body extensions (Fig. 2) are used for extending the proximal body of an
in situ endovascular graft .
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Main Body Extension Preparation/Flush

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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
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the hemostatic valve . (Fig. 7) 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
Sheath
of air .
(Fr)
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
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liberally .
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Main Body Extension Placement and Deployment

1 . Replace J tip wire guide with stiff wire guide (LES), .035 inch, 260 cm long,
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and advance through catheter and up to the thoracic aorta . Remove flush
16 catheter and sheath . Maintain wire guide position .
2 . An angiographic catheter should be introduced via the contralateral
femoral artery and positioned at the level of the required implant site .
3 . Introduce the main body extension delivery system into the ipsilateral
femoral artery .
CAUTION: The main body extension delivery system cannot be introduced
through a main body or iliac leg introducer sheath.
4 . Advance slowly until the main body extension is at the site of the required
intervention . (Fig. 10)
5 . Verify main body extension position to ensure proper sealing and
resistance to migration .
6 . Verify placement with angiography to ensure that the renal arteries remain
patent and that proper placement is achieved .
CAUTION: Care should be taken not to displace the main body graft
during the placement and deployment of the main body extension.
NOTE: Ensure the Captor Hemostatic Valve on the Flexor Introducer sheath is
turned to the open position . (Fig.11)
7 . Use the gripper to stabilize the gray positioner while withdrawing the
sheath . (Figs. 12 and 13) Continue to deploy the device until the most
distal stent is uncovered . (Fig. 14) Stop withdrawing the sheath .
8 . 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. 15)
9 . Withdraw the tapered tip of the introducer back through the main body
extension graft and sheath while maintaining wire guide position . Ensure
the main body extension and endovascular graft are not displaced during
withdrawal of delivery system .
10 . Close the Captor Hemostatic Valve on the main body extension introducer
sheath by turning it in a clockwise direction until it stops . (Fig. 16)
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