Device Description; Intended Use; Contraindications; Warnings And Precautions - COOK Medical Zenith TX2 Gebrauchsanweisung

Zenith TX2 TAA Endovascular Graft with Pro-Form™
® ®
and the Z-Trak
®
These recommendations are designed to serve only as a general guideline. They are not intended to
supersede institutional protocols or professional clinical judgement concerning patient care.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician
(or properly licensed practitioner).

1. DEVICE DESCRIPTION

1.1 Zenith TX2 TAA Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System
The Zenith TX2 TAA Endovascular Graft with Pro-Form is a two-piece cylindrical endovascular graft
consisting of proximal and distal components. The proximal components can be either non-tapered or
tapered. The stent grafts are constructed of full-thickness woven polyester fabric sewn to self-expand-
ing stainless steel Cook-Z stents with braided polyester and monofilament polypropylene suture. (Fig. 1)
The Zenith TX2 TAA Endovascular Graft with Pro-Form is fully stented to provide stability and the ex-
pansile force to open the lumen of the graft during deployment. Additionally, the Cook-Z stents provide
the attachment and seal of the graft to the vessel wall.
For added fixation, the covered stent at the proximal end of the proximal component contains barbs
placed at a 2 mm stagger, which protrude through the graft material. In addition, the bare stent at the
distal end of the distal component also contains barbs. To facilitate fluoroscopic visualization of the
stent graft, four radiopaque gold markers are positioned on each end of the proximal and distal com-
ponents. These markers are placed in a circumferential orientation within 1 mm of the most proximal
aspect of the graft material and within 1 mm of the most distal aspect of the graft material.
The Zenith TX2 TAA Endovascular Graft with Pro-Form is shipped preloaded onto either a 20 French or
22 French Z-Trak Plus Introduction System. (Fig. 2) It has a sequential deployment method with built-in
features to provide continuous control of the endovascular graft throughout the deployment proce-
dure. The Z-Trak Plus Introduction System is designed for precise positioning before deployment of the
proximal and/or distal components. The proximal component uses a single trigger-wire release mecha-
nism. The distal component uses a dual trigger-wire release mechanism. The trigger-wires secure the
endovascular graft onto the delivery system until released by the physician. (Fig. 3) All delivery systems
feature Flexor introducer sheaths, which are designed to resist kinking and are hydrophilically coated.
®
Both features are intended to enhance trackability in the iliac arteries and thoracic aorta.
1.2 Zenith TX2 TAA Endovascular Graft with Pro-Form Ancillary Components
Ancillary endovascular components (proximal and distal body extensions) are available. (Fig. 1)
The Zenith TX2 TAA Endovascular Graft with Pro-Form Ancillary Components are cylindrical compo-
nents constructed from the same polyester fabric, self-expanding stainless steel Cook-Z stents, and
polypropylene suture used in constructing the principal graft components. At the distal and proximal
graft margins, the stents are attached to the inner surface. Elsewhere the stents are sutured on the
external surface. The proximal extension contains proximal attachment barbs and the distal extension
does not have barbs. Both the proximal and distal main body extensions can be used to provide ad-
ditional length to their respective portions of the endovascular graft. Additionally, the distal main body
extension can be used to increase the overlap length between components.
1.2.1 Zenith TX2 TAA Endovascular Graft with Pro-Form Proximal Extensions
The Zenith TX2 TAA Endovascular Graft with Pro-Form Proximal Extension is deployed from either a 20
French or 22 French Z-Trak Plus Introduction System. (Fig. 2) A single trigger-wire release mechanism
locks the endovascular graft onto the delivery system until released by the physician. All systems are
compatible with a .035 inch wire guide.
The covered stent at the proximal end of the proximal extension contains barbs placed at a 2 mm stag-
ger, which protrude through the graft material. To facilitate fluoroscopic visualization of the proximal
extension, four radiopaque markers are positioned on the ends of the graft in a circumferential orienta-
tion within 1 mm of the most proximal and distal aspects of the graft material.
1.2.2 Zenith TX2 TAA Endovascular Graft with Pro-Form Distal Extensions
The Zenith TX2 TAA Endovascular Graft with Pro-Form Distal Extension is deployed from either a 20
French or 22 French Z-Trak Plus Introduction System. (Fig. 2) A single trigger-wire release mechanism
locks the endovascular graft onto the delivery system until released by the physician. All systems are
compatible with a .035 inch wire guide.
To facilitate fluoroscopic visualization of the distal extension, four radiopaque markers are positioned
on the ends of the graft in a circumferential orientation within 1 mm of the most proximal and distal
aspects of the graft material.

2. INTENDED USE

The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System is
intended for treatment of patients with aterosclerotic aneurysms, symptomatic acute or chronic dissec-
tions, contained ruptures, growing aneurysms and/or resulting in distal ischemia, in the descending
thoracic aorta having vascular morphology suitable for endovascular repair (Fig. 5), including:
• Adequate iliac/femoral access compatible with the required introduction systems,
• Radius of curvature greater than 35 mm along the entire length of aorta intended to be treated,
• Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm:
• with a length of at least 20 mm
• with a diameter measured outer wall to outer wall of no greater than 38 mm and no less than
20 mm, and
• with an angle less than 45 degrees.

3. CONTRAINDICATIONS

The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System is con-
traindicated in:
• Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypro-
pylene, nitinol, or gold.
• Patients with a systemic infection who may be at increased risk of endovascular graft infection.

4. WARNINGS AND PRECAUTIONS

4.1 General
• Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions
may lead to serious consequences or injury to the patient.
I-TX2-PRO-FORM-1002-361-02
Plus Introduction System
ENGLISH 1