COOK Medical Zenith TX2 Gebrauchsanweisung Seite 7

• 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, 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 POST-OPERATIVE FOLLOW-UP.
• The Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction System
is not recommended in patients unable to undergo, or who will not be compliant with, the neces-
sary pre-operative and post-operative imaging and implantation studies as described in Section 12,
IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP.
• After endovascular graft placement, patients should be regularly monitored for endoleak flow,
aneurysm growth, or changes in the structure or position of the endovascular graft. At a minimum,
annual imaging is required, including: 1) chest radiographs to examine device integrity (separation
between components, stent fracture, device position, and/or barb separation); and 2) contrast and
non-contrast CT to examine aneurysm changes, endoleak flow, patency, tortuosity, device position
and progressive disease. If renal complications or other factors preclude the use of image contrast
media, chest radiographs and non-contrast CT may be used in combination with transesophageal
echocardiography (for endoleak assessment) to provide similar, although suboptimal, information.
4.4 Device Selection
• The recommended amount of overlap between devices is 3-4 stents. However, the proximal sealing
stent of the proximal component or distal sealing stent of the distal component should not be over-
lapped, as doing so may cause malapposition to the vessel wall. The minimum required amount of
overlap between devices is 2 stents (~50 mm) – less than 2 stents may result in endoleak (with or
without component separation). Device lengths should be selected accordingly.
• Strict adherence to the Zenith TX2 TAA Endovascular Graft with Pro-Form IFU sizing guide is
strongly recommended when selecting the appropriate device size (Tables 10.1 and 10.2). Appropri-
ate device oversizing has been incorporated into the IFU sizing guide. Sizing outside of this range
can result in endoleak, fracture, migration, device infolding, or compression.
4.5 Implant Procedure
(Refer to Section 10, DIRECTIONS FOR USE)
• Appropriate procedural imaging is required to successfully position the Zenith TX2 TAA Endovascu-
lar Graft with Pro-Form in the neck and to assure appropriate apposition to the aortic wall.
• Do not bend or kink the delivery system. Doing so may cause damage to the delivery system and
the Zenith TX2 TAA Endovascular Graft with Pro-Form.
• To avoid twisting the endovascular graft, never rotate the delivery system during the procedure. Al-
low the device to conform naturally to the curves and tortuosity of the vessels.
• Do not continue advancing the wire guide or any portion of the delivery system if resistance is felt.
Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur. Exercise par-
ticular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.
• Inadvertent partial deployment or migration of the endoprosthesis may require surgical removal.
• Unless medically indicated, do not deploy the Zenith TX2 TAA 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 and collateral circulation to the spinal cord.
• 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.
• During sheath withdrawal, the proximal barbs are exposed and are in contact with the vessel wall.
At this stage it may be possible to advance the device, but retraction may cause aortic wall damage.
• Landing the proximal and distal ends of the device in parallel aortic neck segments without acute
angulation (>45°) or circumferential thrombus/calcification is important to ensuring fixation and seal.
• Landing the proximal or distal ends of the device in an aortic neck segment with a diameter that dif-
fers from that to which the graft was sized initially may potentially result in inadequate sizing (<10%
or >25%) and therefore migration, endoleak, aneurysm growth, or increased risk of thrombosis.
• Inaccurate placement and/or incomplete sealing of the Zenith TX2 TAA 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.
• Inadequate fixation of the Zenith TX2 TAA Endovascular Graft with Pro-Form may result in in-
creased risk of migration of the stent graft. Incorrect deployment or migration of the endoprosthesis
may require surgical intervention.
• 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.
• 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.
• Minimize handling of the constrained endoprosthesis during preparation and insertion to decrease
the risk of endoprosthesis contamination and infection.
• Maintain wire guide position during delivery system insertion.
• Always use fluoroscopy for guidance, delivery, and observation of the Zenith TX2 TAA Endovascular
Graft with Pro-Form within the vasculature.
• The use of the Zenith TX2 TAA Endovascular Graft with Pro-Form with the Z-Trak Plus Introduction
System requires administration of intravascular contrast. Patients with pre-existing renal insuf-
ficiency may have an increased risk of renal failure post-operatively. Care should be taken to limit
the amount of contrast medium used during the procedure and to observe preventative methods of
treatment to decrease renal compromise (e.g., adequate hydration).
• As the sheath and/or wire guide is withdrawn, anatomy and graft position may change. Constantly
monitor graft position and perform angiography to check position as necessary.
• The Zenith TX2 TAA Endovascular Graft with Pro-Form incorporates a covered proximal stent (on
the proximal component) with fixation barbs and an uncovered distal stent (on the distal compo-
nent) with fixation barbs. Exercise extreme caution when manipulating interventional and angio-
graphic devices in the region of the covered proximal stent and uncovered distal stent. Do not place
the barbs and the uncovered distal stent in an area with dissection.
• Use caution during manipulation of catheters, wires and sheaths within an aneurysm. Significant
disturbances may dislodge fragments of thrombus or plaque, which can cause distal or cerebral
embolization, or cause rupture of the aneurysm.
I-TX2-PRO-FORM-1002-361-02 ENGLISH 3