Patient Counseling Information; How Supplied; Clinical Use Information; Physician Training - COOK Medical Zenith TX2 Instrucciones De Uso

vascular Graft with Pro-Form and the Z-Trak Plus
Introduction System. Additional considerations
for patient selection include but are not limited
to:
• Patient's age and life expectancy.
• Co-morbidities (e.g., cardiac, pulmonary or
renal insufficiency prior to surgery, morbid
obesity).
• Patient's suitability for open surgical repair.
• Ability to tolerate general, regional, or local
anesthesia.
• Ilio-femoral access vessel size and morphol-
ogy (thrombus, calcification and/or tortuosity)
should be compatible with vascular access
techniques and accessories of the delivery
profile of a 20 Fr to 22 Fr vascular introducer
sheath.
• Vascular morphology suitable for endovascu-
lar repair, 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 segment
(fixation site) proximal to the dissection:
• 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.
The final treatment decision is at the discretion of
the physician and patient.
8 PATIENT COUNSELING
INFORMATION
The physician and patient (and/or family mem-
bers) should review the risks and benefits when
discussing this endovascular device and proce-
dure, including:
• Risks and differences between endovascular
repair and open surgical repair.
• Potential advantages of traditional open sur-
gical repair.
• Potential advantages of endovascular repair.
• The possibility that subsequent interventional
or open surgical repair may be required after
initial endovascular repair.
In addition to the risks and benefits of an endo-
vascular repair, the physician should assess the
patient's commitment to and compliance with
post-operative follow-up as necessary to ensure
continuing safe and effective results. Listed
below are additional topics to discuss with the
patient as to expectations after an endovascular
repair:
• 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
specific clinical findings (e.g., endoleaks,
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
POST-OPERATIVE FOLLOW-UP.
• Patients should be counseled on the impor-
tance of adhering to the follow-up schedule,
both during the first year and at yearly inter-
vals thereafter. Patients should be told that
regular and consistent follow-up is a critical
part of ensuring the ongoing safety and ef-
fectiveness of endovascular treatment of dis-
sections. At a minimum, annual imaging and
adherence to routine post-operative follow-
up requirements is required and should be
considered a life-long commitment to the
patient's health and well-being.
• The patient should be told that successful re-
pair does not arrest the disease process. It is
still possible to have associated degeneration
of vessels.
8 ENGLISH
• Physicians must advise every patient that it is
important to seek prompt medical attention
if he/she experiences signs of graft occlusion
or rupture. Signs of graft occlusion include,
but may not be limited to, pain in the hip(s)
or leg(s) during walking or at rest, and dis-
coloration or coolness of the leg(s). Rupture
may be asymptomatic, but usually presents
as pain, numbness, weakness in the legs,
any back or chest pain, persistent cough, diz-
ziness, fainting, rapid heartbeat, or sudden
weakness.
The physician should complete the Patient Card
and give it to the patient so that he/she can carry
it with him/her at all times. The patient should
refer to the card anytime he/she visits additional
health practitioners, particularly for any addi-
tional diagnostic procedures (e.g., MRI).
9 HOW SUPPLIED
• The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduc-
tion System is supplied sterile and pre-loaded
in peel-open packages.
• The device is intended for single use only. Do
not re-sterilize the device.
• 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 oc-
curred, do not use the product and return to
Cook Medical.
• Prior to use, verify correct devices (quantity
and size) have been supplied for the patient
by matching the device to the order pre-
scribed by the physician for that particular
patient.
• The device is loaded into a 20 Fr or 22 Fr
Flexor Introducer Sheath. Its surface is
treated 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 "use by" (expiration)
date printed on the label.
• Store in a dark, cool, dry place.
10 CLINICAL USE INFORMATION
10.1 Physician Training
CAUTION: Always have a qualified surgery team
available during implantation or reintervention
procedures in the event that conversion to open
surgical repair is necessary.
CAUTION: 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 (endovascular and
surgical) and in the use of this device. The rec-
ommended skill/knowledge requirements for
physicians using the Zenith TX2 Dissection En-
dovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System are outlined below:
Patient Selection:
• Knowledge of the natural history of thoracic
dissections and co-morbidities associated
with repair.
• Knowledge of radiographic image interpreta-
tion, patient selection, device selection, plan-
ning and sizing.
A multidisciplinary team that has combined pro-
cedural experience with:
• Femoral and brachial cutdown, arteriotomy,
and repair
• Percutaneous access and closure techniques
• Non-selective and selective wire guide and
catheter techniques
• Fluoroscopic and angiographic image inter-
pretation
• Embolization
• Angioplasty
• Endovascular stent placement
I-ZDEG-EU-1105-394-02