Potential Adverse Events; Potential Risks And Benefits; Patient Selection And Treatment; Individualization Of Treatment - COOK Medical Zenith TX2 Instrucciones De Uso

or equal to 1.4°C at a maximum whole body
averaged specific absorption rate (SAR) of 2.8
W/kg for 15 minutes of MR scanning in a 1.5
Tesla Magnetom, Siemens Medical Magnetom,
Numaris/4 Software, Version Syngo MR 2002B
DHHS MR Scanner. The maximum whole body
averaged specific absorption rate (SAR) was 2.8
W/kg, which corresponds to a calorimetry mea-
sured value of 1.5 W/kg.
3.0 Tesla Systems:
• Static magnetic field of 3.0 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
or equal to 1.9°C at a maximum whole body aver-
aged specific absorption rate (SAR) of 3.0 W/kg,
for 15 minutes of MR scanning in a 3.0 Tesla Ex-
cite, GE Electric Healthcare, G3.0-052B Software,
MR Scanner. The maximum whole body aver-
aged specific absorption rate (SAR) was 3.0 W/
kg, which corresponds to a calorimetry measured
value of 2.8 W/kg.
Image Artifact
The image artifact extends throughout the ana-
tomical region containing the device, obscuring
the view of immediately adjacent anatomical
structures within approximately 20 cm of the
device, as well as the entire device and its lumen,
when scanned in nonclinical testing using the se-
quence: Fast spin echo, in a 3.0 Tesla, Excite, GE
Electric Healthcare, with G3.0-052B software, MR
system with body radiofrequency coil.
For all scanners, the image artifact dissipates as
the distance from the device to the area of inter-
est increases. MR scans of the head and neck
and lower extremities may be obtained without
image artifact. Image artifact may be present
in scans of the abdominal region and upper ex-
tremities, depending on distance from the device
to the area of interest.
Clinical information is available for seventeen
patients who received MRI scans after stent-graft
implantation. There have been no reported ad-
verse events or device problems in any of these
patients as a result of having received an MRI.
5 POTENTIAL ADVERSE EVENTS
Adverse events that may occur and/or require in-
tervention include, but are not limited to:
• Amputation
• Anesthetic complications and subsequent at-
tendant problems (e.g., aspiration)
• Aneurysm enlargement
• Aneurysm rupture and death
• Aortic damage, including perforation, dissec-
tion, bleeding, rupture and death
• Aorto-bronchial fistula
• Aorto-esophageal fistula
• Arterial or venous thrombosis and/or pseu-
doaneurysm
• Arteriovenous fistula
• Bleeding, hematoma, or coagulopathy
• Bowel complications (e.g., ileus, transient
ischemia, infarction, necrosis)
• Cardiac complications and subsequent atten-
dant problems (e.g., arrhythmia, myocardial
infarction, congestive heart failure, hypoten-
sion, hypertension)
• Claudication (e.g., buttock, lower limb)
• Death
• Edema
• Embolization (micro and macro) with tran-
sient or permanent ischemia or infarction
• Endoleak
• Endoprosthesis: improper component place-
ment; incomplete component deployment;
component migration; suture break; occlu-
sion; infection; stent fracture; graft material
wear; dilatation; erosion; puncture; perigraft
flow; barb separation and corrosion
• Fever and localized inflammation
I-ZDEG-EU-1105-394-02
• Genitourinary complications and subsequent
attendant problems (e.g., ischemia, erosion,
fistula, urinary incontinence, hematuria, in-
fection)
• Hepatic failure
• Impotence
• Infection of the dissection, device or access
site, including abscess formation, transient
fever and pain
• Lymphatic complications and subsequent at-
tendant problems (e.g., lymph fistula)
• Local or systemic neurologic complications
and subsequent attendant problems (e.g.,
stroke, transient ischemic attack, paraplegia,
paraparesis, paralysis)
• Occlusion of device or native vessel
• Pulmonary/respiratory complications and
subsequent attendant problems (e.g., pneu-
monia, respiratory failure, prolonged intuba-
tion)
• Renal complications and subsequent atten-
dant problems (e.g., artery occlusion, con-
trast toxicity, insufficiency, failure)
• Surgical conversion to open repair
• Vascular access site complications, including
infection, pain, hematoma, pseudoaneurysm,
arteriovenous fistula
• Wound complications and subsequent atten-
dant problems (e.g., dehiscence, infection)
• Vascular spasm or vascular trauma (e.g., ilio-
femoral vessel dissection, bleeding, rupture,
death)
6 POTENTIAL RISkS AND BENEFITS
The device is an implantable endoprosthesis in-
tended to reduce the risk of rupture. The hazards
associated can be categorized as device-related
(e.g., lack of sterility, toxicity, biodegredation
of the device), deployment-related (e.g., failure
to traverse the iliac arteries, misdeployment),
performance-related (e.g., migration, stent
fracture, graft infection, late endoleak), and
disease-related (e.g., extension of the dissection,
malperfusion, and aneurysm degeneration). The
consequent risks to the patient depend on the
incidence and effects of each hazard, which have
been explored in a number of experimental and
clinical insertions. These risks of endovascular
repair must be weighed against the risks associ-
ated with the current alternative forms of tho-
racic aortic dissection management.
Implantation of the Zenith TX2 Dissection En- dovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System is likely a less invasive
procedure than open surgical repair. Therefore,
potential clinical benefits to patients treated with
the Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduc-
tion System may include a suitable dissection
repair with less risk and fewer complications
than those treated with open surgical repair.
Zenith TX2 Dissection Endovascular Graft with
Pro-Form and the Z-Trak Plus Introduction Sys-
tem patients may benefit from a reduced risk of
serious treatment-related complications, shorter
anesthesia times, shorter procedure times, re-
duced procedural blood loss and reduced need
for blood products.
7 PATIENT SELECTION AND
TREATMENT
(See Section 4, WARNINGS AND P RECAUTIONS)
7.1 Individualization of Treatment
Cook recommends that the Zenith TX2 Dissec-
tion Endovascular Graft with Pro-Form and the
Z-Trak Plus Introduction System component
diameters be selected as described in Tables 1,
2 and 3. All lengths and diameters of the devices
necessary to complete the procedure should be
available to the physician, especially when pre-
operative case planning measurements (treat-
ment diameters/lengths) are not certain. This
approach allows for greater intra-operative flex-
ibility to achieve optimal procedural outcomes.
The risks and benefits previously described in
Section 6, POTENTIAL RISkS AND BENEFITS
should be carefully considered for each patient
before use of the Zenith TX2 Dissection Endo-
ENGLISH 7