Intended Use; Contraindications; Warnings And Precautions; General - COOK Medical Zenith TX2 Instrucciones De Uso

2 INTENDED USE
Fig. 4
Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System/
Zenith Dissection Endovascular Stent with the H&L-B One-Shot Introduction System
proximal neck length
Zenith Dissection Endovascular Stent with
the H&L-B One-Shot Introduction System
The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction
System is indicated for the endovascular treat-
ment 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 Straight 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 Introduc-
tion System is contraindicated in:
• Patients with known sensitivities or allergies
to stainlesss steel, polyester, solder (tin, sil-
ver), polypropylene, nitinol or gold.
• Patients with a systemic infection who may
be at increased risk of endovascular graft in-
fection.
4 WARNINGS AND PRECAUTIONS
4.1 General
• Read all instructions carefully. Failure to
properly follow the instructions, warnings,
and precautions may lead to serious conse-
quences or injury to the patient.
• The Zenith TX2 Dissection Endo vascular
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 pa-
tients 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 specif-
ic clinical findings (e.g., endoleaks, enlarging
aneurysms, persisting flow in false lumen,
or changes in the structure or position of the
I-ZDEG-EU-1105-394-02
proximal neck diameter
20-38 mm
> 20 mm
aortic radius
> 35 mm
distal aortic diameter 20-38 mm
endovascular graft) should receive enhanced
follow-up. Specific follow-up guidelines are
described in Section 12,
IMAGING GUIDELINES AND POST-OPERA-
TIVE 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)
chest radiographs to examine device integ-
rity (separation between components, stent
fracture, or barb separation); 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 modali-
ties (e.g., TEE, IVUS) should be considered in
combination with non-contrast CT.
• The Zenith TX2 Dissection Endo vascular Graft
with Pro-Form and the Z-Trak Plus Introduc-
tion System is not recommended in patients
unable to undergo, or who will not be com-
pliant with, the necessary pre-operative and
post-operative imaging and implantation
studies as described in Section 12, IMAG-
ING GUIDELINES AND POST-OPERATIVE
FOLLOW-UP.
• Additional endovascular interventions or
conversion to standard open surgical repair
following initial endovascular repair should
be considered for patients experiencing unac-
ceptable decrease in fixation length (vessel
and component overlap) and/or endoleak.
• Patients experiencing reduced blood flow
through the graft and/or leaks may be re-
quired to undergo secondary endovascular
interventions or surgical procedures.
• Always have a qualified surgery team avail-
able during implantation or reintervention
procedures in the event that conversion to
open surgical repair is necessary.
• Interventions such as defibrillation, cardiover-
sion, or CPR, although not specifically evalu-
ated 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 delivery systems of the pro-
file of a 20 Fr or 22 Fr vascular introducer
ENGLISH 5