How Supplied - COOK Medical Zenith TX2 Gebrauchsanweisung

8. HOW SUPPLIED

• The Zenith TX2 TAA Endovascular Graft with Pro-Form is supplied ETO-sterilized and preloaded in
peel-open packages. The device is designed for single-use only. Attempts to reprocess, re-sterilize
and/or re-use the device may lead to device failure and/or transmission of disease.
• 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 match-
ing 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
with a hydrophilic coating that, when hydrated, enhances trackability. To activate the hydrophilic
coating, the surface must be wiped with a 4X4 gauze pad soaked in saline solution.
• Do not use after the expiration date printed on the label.
• Store in a dark, cool, dry place.
9. CLINICAL USE INFORMATION
9.1 Physician Training
CAUTION: Always have a qualified surgery team available during implantation or reintervention proce-
dures in the event that conversion to open surgical repair is necessary.
CAUTION: The Zenith TX2 TAA Endovascular Graft with Pro-Form with 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 require-
ments for physicians using the Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus
Introduction System are outlined below:
Patient selection:
• Knowledge of the natural history of thoracic aortic aneurysms (TAA), and co-morbidities associated
with TAA 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
• Non-selective 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
9.2 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.
9.3 Materials Required
(Not included in two-piece modular system)
• A selection of Zenith TX2 TAA Endovascular Graft with Pro-Form proximal and distal ancillary com-
ponents in diameters compatible with the two-piece system are available.
• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Power injector
• Syringe
• Heparinized saline solution
• Sterile 4X4 gauze pads
9.4 Materials Recommended
(Not included in two-piece modular system)
The following products are recommended for implantation of any component in the Zenith product line.
For information on these products, refer to the individual product's Suggested Instructions For Use.
• .035 inch (0.89 mm) extra stiff wire guide, 260 cm; for example:
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• Cook Lunderquist 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
• Molding Balloons; for example:
• Cook CODA
®
• Introducer sets; for example:
• Cook Check-Flo
• Sizing catheter; for example:
• Cook Aurous
• Angiographic radiopaque marker catheters; for example:
• Cook Beacon
• Cook Beacon
• Entry needles; for example:
• Cook single wall entry needles
6 ENGLISH
Wire Guides
®
Balloon Catheter
Introducer Sets
®
Centimeter Sizing Catheters
®
Tip Angiographic Catheters
®
Tip Royal Flush Catheters
®
Introducer Sheath. Its surface is treated
®
I-TX2-PRO-FORM-1002-361-02