Implant Procedure; Molding Balloon Use - Optional; Mri Information - COOK Medical Zenith TX2 Instrucciones De Uso

sheath. Vessels that are significantly calcified,
occlusive, tortuous or thrombus-lined may
preclude femoral introduction of the endo-
vascular graft and/or may increase the risk of
embolization.
• Key anatomic elements that may affect suc-
cessful exclusion of the dissection include
severe angulation localized angulation > 45
degrees); short proximal fixation site (< 20
mm); an inverted funnel shape at the proxi-
mal fixation site (greater than 10% increase
in diameter over 20 mm of fixation site
length); and circumferential thrombus and/
or calcification at the arterial fixation sites.
Irregular calcification and/or plaque may
compromise the attachment and sealing at
the fixation site. Necks exhibiting these key
anatomic elements may be more conducive
to graft migration.
• The Zenith TX2 Dissection Endo vascular
Graft with Pro-Form and the Z-Trak Plus In-
troduction System is not recommended for
patients who cannot tolerate contrast agents
necessary for intra-operative and post-opera-
tive follow-up imaging.
• The Zenith TX2 Dissection Endo vascular
Graft with Pro-Form and the Z-Trak Plus In-
troduction System is not recommended for
patients whose weight or size would com-
promise or prevent the necessary imaging
requirements.
• Graft implantation may increase the risk of
paraplegia where graft exclusion covers the
origins of dominant spinal cord or intercostal
arteries.
• Patients with connective tissue disorders
have not been evaluated.
• Highly patent intercostal aortic branches or
large collateral vessels are likely to result in
retrograde flow after thoracic graft implanta-
tion. Patients with uncorrectable coagulopa-
thy may also have an increased risk of Type II
endoleak or bleeding complications.
4.3 Implant Procedure
• Systemic anticoagulation should be used
during the implantation procedure based on
hospital and physician preferred protocol. If
heparin is contraindicated, an alternative an-
ticoagulant should be used.
• Minimize handling of the constrained endo-
prosthesis during preparation and insertion
to decrease the risk of endoprosthesis con-
tamination and infection.
• To activate the hydrophilic coating on the
outside of the sheath, the surface must be
wiped with 4X4 gauze pads soaked in saline
solution. Always keep the sheath hydrated
for optimal performance.
• Maintain wire guide position during delivery
system insertion.
• Do not bend or kink the delivery system.
Doing so may cause damage to the delivery
system and the Zenith TX2 Dissection Endo-
vascular Graft with Pro-Form and the Z-Trak
Plus Introduction System.
• Always use fluoroscopy for guidance, de-
livery, and observation of the Zenith TX2
Dissection Endovascular Graft with Pro-Form
and the Z-Trak Plus Introduction System
within the vasculature.
• The use of the Zenith TX2 Dissection Endo-
vascular Graft with Pro-Form and the Z-Trak
Plus Introduction System requires adminis-
tration of intravascular contrast. Patients with
pre-existing renal insufficiency may have an
increased risk of renal failure post-operative-
ly. Care should be taken to limit the amount
of contrast media used during the procedure.
• To avoid twisting the endovascular graft, nev-
er rotate the delivery system during the pro-
cedure. Allow the device to conform naturally
to the curves and tortuosity of the vessels.
• As the sheath is withdrawn, anatomy and
graft position may change. Constantly moni-
tor graft position and perform angiography
to check position as necessary.
6 ENGLISH
• Inaccurate placement and/or incomplete seal-
ing of the Zenith TX2 Dissection Endovascular
Graft with Pro-Form and the Z-Trak Plus Intro-
duction System within the vessel may result
in increased risk of endoleak, migration, or
inadvertent occlusion of the left subclavian,
left common carotid, and/or celiac arteries.
• Incorrect deployment or migration of the en-
doprosthesis may require surgical interven-
tion.
• Do not continue advancing the wire guide
or any portion of the delivery system if re-
sistance is felt. Stop and assess the cause of
resistance; vessel, catheter, or graft damage
may occur. Exercise particular care in areas of
stenosis, intravascular thrombosis, or calci-
fied or tortuous vessels.
• Unless medically indicated, do not deploy
the Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduc-
tion System in a location that will occlude
arteries necessary to supply blood flow to or-
gans or extremities. Do not cover significant
arch or mesenteric arteries (exception may be
the left subclavian artery) with the endopros-
thesis. Vessel occlusion may occur. If a left
subclavian artery is to be covered with the
device, the clinician should be aware of the
possibility of compromise to cerebral and up-
per limb circulation.
• Use caution during manipulation of catheters,
wires and sheaths within a dissection. Signifi-
cant disturbances may dislodge fragments of
thrombus, which can cause distal or cerebral
embolization.
• Avoid damaging the graft or disturbing graft
positioning after placement in the event rein-
strumentation (secondary intervention) of the
graft is necessary.
• Do not attempt to re-sheath the graft after
partial or complete deployment.
• Repositioning the stent graft distally after par-
tial deployment of the covered proximal stent
may result in damage to the stent graft and/
or vessel injury.
• To avoid impaling any catheters left in situ,
rotate the delivery system during withdrawal.
4.4 Molding Balloon Use - Optional
• Confirm complete deflation of balloon prior
to repositioning.
• Do not inflate balloon in aorta outside of
graft.
• Use caution during molding within a dissec-
tion
• For added hemostasis, the Captor™ Hemo-
static Valve can be loosened or tightened to
accomodate the insertion and subsequent
withdrawal of a molding balloon.
4.5 MRI Information
Non-clinical testing has demonstrated that the
Zenith TX2 Endovascular Graft with the Z-Trak
Plus Introduction System is MR Conditional. It
can be scanned safely immediately after place-
ment under the following conditions.
Static Magnetic Field
• Static magnetic field of 3.0 Tesla or less.
• Highest spatial magnetic gradient field of 720
Gauss/cm
Non-clinical evaluation was conducted in a 3
Tesla MR system (General Electric Excite) with a
maximum spatial magnetic gradient field of 720
Gauss/cm as measured with a gaussmeter in the
position of the static magnetic field pertinent to
the patient (i.e., outside of scanner covering, ac-
cessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Systems:
• Static magnetic field of 1.5 Tesla
• Maximum whole body averaged specific ab-
sorption rate (SAR) of 2 W/kg for 15 minutes
of scanning (i.e., per scanning sequence)
In non-clinical testing, the Zenith TX2 TAA Endo-
vascular Graft with the Z-Trak Plus Introduction
System produced a temperature rise of less than
I-ZDEG-EU-1105-394-02