Clinical Use Information; Physician Training; Patient Selection; A Multidisciplinary Team That Has Combined Procedural Experience With - COOK Medical Zenith TX2 Instrucciones De Uso

• Prior to use, verify correct devices (quantity and size) have been supplied for
the patient by matching the device to the order prescribed by the physician
for that particular patient.
• The device is loaded into a 20 French or 22 French Flexor Introducer Sheath.
Its surface is treated with a hydrophilic coating that, when hydrated,
enhances trackability. To activate the hydrophilic coating, the surface must
be wiped with a sterile gauze pad soaked in saline solution.
• Do not use after the "use by" (expiration) date printed on the label.
• Store in a dark, cool, dry place.

10 CLINICAL USE INFORMATION

10.1 Physician Training

CaUTIoN: always have a qualified surgery team available during
implantation or reintervention procedures in the event that conversion to
open surgical repair is necessary.
CaUTIoN: The zenith TX2 Dissection Endovascular Graft with Pro-form
and the z-Trak Plus Introduction System should only be used by physicians
and teams trained in vascular interventional techniques (endovascular and
surgical) and in the use of this device. The recommended skill/knowledge
requirements for physicians using the zenith TX2 Dissection Endovascular
Graft with Pro-form and the z-Trak Plus Introduction System are outlined
below:

Patient Selection:

• Knowledge of the natural history of thoracic dissections and co-morbidities
associated with repair.
• Knowledge of radiographic image interpretation, patient selection, device
selection, planning and sizing.
A multidisciplinary team that has combined procedural experience
with:
• Femoral and brachial cutdown, arteriotomy, and repair or conduit technique
• Percutaneous access and closure techniques
• Nonselective and selective wire guide and catheter techniques
• Fluoroscopic and angiographic image interpretation
• Embolization
• Angioplasty
• Endovascular stent placement
• Snare techniques
• Appropriate use of radiographic contrast material
• Techniques to minimize radiation exposure
• Expertise in necessary patient follow-up modalities
Table 1 Straight Component and Tapered Component Graft Diameter Sizing Guide*
Intended aortic
vessel Diameter
1,2
(mm)
20
21
22/23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
*All dimensions are nominal.
1 Maximum diameter along the fixation site, measured outer wall to outer wall.
2 Round measured aortic diameter to nearest mm.
3 Additional considerations may affect choice of diameter.

11 DIRECTIONS FOR USE

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 TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System. The Zenith TX2 Dissection Endovascular Graft with
Pro-Form and the Z-Trak Plus 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 introduction system(s)
2. Angulation of aorta, aneurysm and iliac arteries
3. Quality of the proximal and distal fixation sites
4. Diameters of proximal and distal fixation sites and distal iliac arteries
overall Length of
Graft Diameter Straight Component
3
(mm)
22 79/117
24 79/117
26 79/136
28 82/142/202
30 82/142/202
30 82/142/202
30 82/142/202
32 82/142/202
32 82/142/202
34 79/154/204
36 79/154/204
36 79/154/204
38 79/154/204
38 79/154/204
40 83/164/218
40 83/164/218
42 83/164/218
42 83/164/218

10.2 Inspection Prior to Use

Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken. If damage has occurred, do
not use the product and return to Cook.
Prior to use, verify correct devices (quantity and size) have been supplied for the
patient by matching the device to the order prescribed by the physician for that
particular patient.

10.3 Materials Required

(Not included with the Zenith TX2 Dissection Endovascular Graft with Pro-Form
and the Z-Trak Plus Introduction System). For information on the use of these
products, refer to the individual product's instructions for use.
• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Power injector
• Zenith Dissection Endovascular Stent
• Syringe
• Heparinized saline solution
• Sterile gauze pads
• .035 inch (0.89 mm) extra stiff wire guide, 260/300 cm; for example:
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• Cook Lunderquist™ DC Extra Stiff Wire Guides (LESDC)
• .035 inch (0.89 mm) standard wire guide; for example:
• Cook .035 inch Wire Guides
• Cook .035 inch Bentson Wire Guide
• Cook Nimble® Wire Guides
• Molding Balloons; for example:
• Cook Coda® Balloon Catheter
• Introducer sets; for example:
• Cook Check-Flo® Introducer Sets
• Sizing catheter; for example:
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque marker catheters; for example:
• Cook Beacon® Tip Angiographic Catheters
• Cook Beacon® Tip Royal Flush® Catheters
• Entry needles; for example:
• Cook Single Wall Entry Needles

10.4 Device Diameter 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, see Table 1.
overall Length
of 4 mm Tapered
(mm) Component (mm)
162/202
162/202
159/199
159/199
159/199
154/204
154/204
160/210
160/210
160/210
160/210

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 femoral artery using standard surgical technique.
4. Establish adequate proximal and distal vascular control of femoral artery.
11.1 The Zenith TX2 Dissection Endovascular Graft with Pro-Form
and the Z-Trak Plus Intro duction System Preparation/Flush
1. Remove yellow-hubbed shipping stylet (from the inner cannula) and
cannula protector tube (at the handle). Remove Peel-Away sheath from
back of valve assembly (fig. 5).
2. Elevate distal tip of system and flush through the hemostatic valve until
fluid emerges from the tip of the introduction sheath (fig. 6). Continue
to inject a full 60 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.
3. Attach syringe with heparinized saline to the hub on the inner cannula.
Flush until fluid exits the distal sideports and dilator tip (fig. 7).
4. Soak sterile gauze pads in saline solution and use to wipe the Flexor
Introducer Sheath to activate the hydrophilic coating. Hydrate both sheath
and dilator tip liberally.
11.1.1 Placement of The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction System
1. Puncture the selected artery using standard technique with an 18 gauge
access needle. Upon vessel entry, insert:
• Wire guide – standard .035 inch, 260/300 cm, 15 mm J tip or Bentson wire
guide
overall Length
of 8 mm Tapered Introducer Sheath
Component (mm)
158/196
158/196
156/194
159/199
159/199
159/199
159/199
165/205
165/205
160/210
160/210
(fr)
20
20
20
20
20
20
20
20
20
20
22
22
22
22
22
22
22
22
15