Device Description; Zenith Tx2 Dissection Endovascular Graft With Pro-Form And The Z-Trak Plus Introduction System; Thoracic Z-Trak Plus Introduction System; Intended Use - COOK Medical Zenith TX2 Instrucciones De Uso

ENGLISH
zENITH® TX2® DISSECTIoN ENDovaSCULar
GrafT WITH Pro-form® aND THE z-Trak® PLUS
INTroDUCTIoN SySTEm
read all instructions carefully. failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to
the patient.
CaUTIoN: federal (U.S.a.) law restricts this device to sale by or on the order
of a physician.
CaUTIoN: all contents of the inner pouch (including the introduction
system and endovascular graft) are supplied sterile, for single use only.

1 DEVICE DESCRIPTION

1.1 Zenith TX2 Dissection Endovascular Graft with Pro-Form and
the Z-Trak Plus Introduction System
When treating dissections of the descending thoracic aorta, the Zenith TX2
Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction
System is typically used in conjunction with the Zenith® Dissection Endovascular
Stent. The Zenith TX2 Dissection Endovascular Graft with Pro-Form and the
Z-Trak Plus Introduction System is for sealing of entry tear(s). The Zenith
Dissecton Endovascular Stent provides support to delaminated segments of
the aorta. For information regarding the use and deployment of the Zenith
Dissection Endovascular Stents, please refer to the Instructions for Use.
The Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System shortest Straight Components can be used to provide
additional length to the endovascular graft, both proximal and distal. Ensure
there is a minimum overlap of 2 stents. The stent graft is constructed of full-
thickness woven polyester fabric sewn to self-expanding stainless steel Cook-Z
stents with braided polyester and monofilament polypropylene suture (fig. 1).
The Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus
Introduction System is fully stented to provide stability and the expansile force
necessary to open the lumen of the graft during deployment. Additionally, the
Cook-Z stents provide the necessary attachment and seal of the graft to the
vessel wall.
To facilitate fluoroscopic visualization of the stent graft, four radiopaque
markers are positioned on each end of the Straight Component or Tapered
Component. 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.

1.2 Thoracic Z-Trak Plus Introduction System

The Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus
Introduction System is shipped preloaded onto the Z-Trak Plus Introduction
System. It has a sequential deployment method with built-in features to pro-
vide continuous control of the endovascular graft throughout the deployment
procedure. The Z-Trak Plus Introduction System enables precise positioning
before deployment of the Straight Component or Tapered Component. The
straight and tapered graft components are deployed from a 20 French or 22
French Z-Trak Plus Intro duc tion System. These systems use a single trigger-
wire release mechanism to secure the endovascular graft onto the delivery
introduction system until released by the physician (fig. 2). All introduction
systems are compatible with a .035 inch wire guide. For added hemostasis, the
Captor® Hemostatic Valve can be loosened or tightened for the introduction
and/or removal of ancillary devices into and out of the sheath. All introduction
systems feature Flexor® introducer sheaths, which resist kinking and are
hydrophilically coated. Both features are intended to enhance trackability in the
iliac arteries and thoracic aorta.
To facilitate sheath withdrawal, each graft component is kept in a longitudinally
stretched condition on the introduction system by locking trigger-wires (fig. 3).
These trigger-wires work in tandem to deliver sequential controlled release of
the Zenith TX2 Dissection Endovascular Graft with Pro-Form during deployment
(fig. 3).

2 INTENDED USE

The Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus
Introduction System is indicated for the endovascular treatment of patients
with symptomatic dissection of the descending thoracic aorta having vascular
morphology suitable for endovascular repair (fig. 4), including:
• Adequate iliac/femoral access compatible with the required introduction
systems,
• Radius of curvature greater than 35 mm along the length of aorta intended
to be treated by Straight or Tapered Component,
• Non-dissected/aneurysmal aortic segments (fixation sites) proximal to the
entry tear:
• 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 localized angulation less than 45 degrees.

3 CONTRAINDICATIONS

The Zenith TX2 Dissection Endovascular Graft with Pro-Form and with the Z-Trak
Plus Introduction System is contraindicated in:
• Patients with known sensitivities or allergies to stainless steel, polyester,
polypropylene, 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.
• The Zenith TX2 Dissection Endo v ascular Graft with Pro-Form and the Z-Trak
Plus Introduction System should only be used by physicians and teams
trained in vascular interventional techniques (catheter-based and surgical)
and in the use of this device. Specific training expectations are described in
Section 10.1, Physician Training.
• The long-term performance of endovascular grafts has not yet been
established. All patients should be advised that endovascular treatment
requires life-long, regular follow-up to assess their health and the
performance of their endovascular graft. Patients with specific clinical
findings (e.g., endoleaks, enlarging aneurysms, persisting flow in false lumen,
or changes in the structure or position of the endovascular graft) should
receive enhanced follow-up. Specific follow-up guidelines are described in
Section 12, ImaGING GUIDELINES aND PoSToPEraTIvE foLLoW-UP.
• After endovascular graft placement, patients should be regularly monitored
for perigraft flow or changes in the structure or position of the endovascular
graft. At a minimum, annual imaging is required, including: 1) thoracic
device radiographs to examine device integrity (separation between
components or stent fracture); and 2) contrast and non-contrast CT to
examine perigraft flow, patency, tortuosity, device position and progressive
disease. If renal complications or other factors preclude the use of image
contrast media, use of other imaging modalities (e.g., TEE, IVUS) should be
considered in combination with non-contrast CT.
• The Zenith TX2 Dissection Endo v ascular Graft with Pro-Form and the
Z-Trak Plus Introduction System is not recommended in patients unable to
undergo, or who will not be compliant with, the necessary preoperative and
postoperative imaging and implantation studies as described in Section 12,
ImaGING GUIDELINES aND PoSToPEraTIvE foLLoW-UP.
• Additional endovascular interventions or conversion to standard open
surgical repair following initial endovascular repair should be considered for
patients experiencing unacceptable decrease in fixation length (vessel and
component overlap) and/or endoleak.
• Patients experiencing reduced blood flow through the graft and/or leaks
may be required to undergo secondary endovascular interventions or
surgical procedures.
• Always have a qualified surgery team available during implantation or
reintervention procedures in the event that conversion to open surgical
repair is necessary.
• Interventions such as defibrillation, cardioversion, or CPR, although not
specifically evaluated in studies, may have the potential to disrupt position
or seal of the endograft, and should be followed by imaging to confirm
continued device function.

4.2 Patient Selection, Treatment and Follow-Up

• Access vessel diameter (measured inner wall to inner wall) and morphology
(tortuosity, oc clusive disease, and/or calcification) should be compatible
with vascular access techniques and introduction systems of the profile
of a 20 French or 22 French vascular introducer sheath. Vessels that are
significantly calcified, occlusive, tortuous or thrombus-lined may preclude
femoral introduction of the endovascular graft and/or may increase the risk
of embolization.
• Key anatomic elements that may affect successful exclusion of the dissection
include severe angulation (localized angulation > 45 degrees); short
proximal fixation site (< 20 mm); an inverted funnel shape at the proximal
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 v ascular Graft with Pro-Form and the Z-Trak
Plus Introduction System is not recommended for patients who cannot
tolerate contrast agents necessary for intraoperative and postoperative
follow-up imaging.
• The Zenith TX2 Dissection Endo v ascular Graft with Pro-Form and the Z-Trak
Plus Introduction System is not recommended for patients whose weight or
size would compromise 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 implantation. Patients
with uncorrectable coagulopathy 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 anticoagulant should be used.
• Minimize handling of the constrained endoprosthesis during preparation
and insertion to decrease the risk of endoprosthesis contamination and
infection.
• To activate the hydrophilic coating on the outside of the sheath, the surface
must be wiped with sterile gauze pads soaked in saline solution. Always
keep the sheath hydrated for optimal performance.
• Maintain wire guide position during introduction system insertion.
• Do not bend or kink the introduction system. Doing so may cause damage
to the introduction system and the Zenith TX2 Dissection Endovascular Graft
with Pro-Form.
• Always use fluoroscopy for guidance, delivery, 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 Endovascular Graft with Pro-Form and
the Z-Trak Plus Introduction System requires administration of intravascular
contrast. Patients with pre-existing renal insufficiency may have an increased
risk of renal failure postoperatively. Care should be taken to limit the amount
of contrast media used during the procedure.
• To avoid twisting the endovascular graft, never rotate the introduction
system during the procedure. 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 monitor graft position and perform angiography to check
position as necessary.
• Inaccurate placement and/or incomplete sealing of the Zenith TX2
Dissection Endovascular Graft with Pro-Form 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 endoprosthesis may require
surgical intervention.
• Do not continue advancing the wire guide or any portion of the introduction
system if resistance 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 calcified or tortuous vessels.
• Unless medically indicated, do not deploy the Zenith TX2 Dissection
Endovascular Graft with Pro-Form in a location that will occlude arteries
necessary to supply blood flow to organs or extremities. Do not cover
significant arch or mesenteric arteries (exception may be the left subclavian
artery) with the endoprosthesis. 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 upper limb
circulation.
• Use caution during manipulation of catheters, wires and sheaths within a
dissection. Significant 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 reinstrumentation (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 partial 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 introduction 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 dissection
• For added hemostasis, the Captor™ Hemostatic Valve can be loosened or
tightened to accomodate the insertion and subsequent withdrawal of a
molding balloon.
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