33
11.3 Abdominal Radiographs
The following views are required:
• Four films: supine-frontal (AP), lateral, 30 degree LPO and 30 degree RPO
views centered on umbilicus .
• Record the table-to-film distance and use the same distance at each
subsequent examination .
Ensure entire device is captured on each single image format lengthwise .
If there is any concern about the device integrity (e .g ., kinking,
stent breaks, barb separation, relative component migration), it is
recommended to use magnified views . The attending physician should
evaluate films for device integrity (entire device length including
components) using 2-4X magnification visual aid .
11.4 MRI Information
NOTE:
If using this device in conjunction with another endovascular graft
from the Zenith family, refer to the appropriate device's IFU for additional
MRI information .
Nonclinical testing has demonstrated that the Zenith Low Profile AAA
Endovascular Graft (The Zenith Low Profile AAA Endovascular Graft served
as a surrogate for the Zenith Alpha Abdominal Endovascular Graft) is MR
Conditional . A patient with this endovascular graft can be scanned safely
immediately after placement under the following conditions:
Static Magnetic Field
• Static magnetic field of 3.0 Tesla or less.
• Spatial magnetic gradient field of 1580 Gauss/cm (15.8 T/m) or less.
• The product of the spatial gradient and static magnetic field should not
exceed 47 .4 T2/m .
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i .e ., outside of scanner
covering, accessible to a patient or individual) .
MRI-Related Heating
1 .5 and 3 .0 Tesla Systems: Maximum whole-body-averaged specific
absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i .e ., per
scanning sequence) .
1.5 Tesla Temperature Rise:
In nonclinical testing, the Zenith Low Profile AAA Endovascular Graft
(The Zenith Low Profile AAA Endovascular Graft served as a surrogate for
the Zenith Alpha Abdominal Endovascular Graft) produced a maximum
temperature rise of 1 .7 °C during 15 minutes of MR imaging (i .e ., for one
scanning sequence) performed in a MR 1 .5 Tesla System (Magnetom,
Siemens Medical Solutions, Malvern, PA, Software Numaris/4) at an MR
system reported whole-body-averaged SAR of 2 .9 W/kg (associated with a
calorimetry measured whole-body-averaged value of 2 .1 W/kg) .
3.0 Tesla Temperature Rise:
In nonclinical testing, the Zenith Low Profile AAA Endovascular Graft
(The Zenith Low Profile AAA Endovascular Graft served as a surrogate for
the Zenith Alpha Abdominal Endovascular Graft) produced a maximum
temperature rise of 2 .0 °C during 15 minutes of MR imaging (i .e ., for
one scanning sequence) performed in a MR 3 .0 Tesla System (Excite, GE
Healthcare, Milwaukee, WI, Software G3 .0-052B) at an MR system reported
whole-body-averaged SAR of 3 .0 W/kg (associated with a calorimetry
measured whole-body-averaged value of 2 .8 W/kg) .
Image Artifact
MR image quality may be compromised if the area of interest is within the
lumen or within approximately 5 mm of the position of the Zenith Alpha
Abdominal Endovascular Graft, as found during nonclinical testing using
the sequences: T1-weighted spin echo and gradient echo pulse in a
3 .0 Tesla MR system (Excite, General Electric Healthcare) . Therefore, it may
be necessary to optimize MR imaging parameters for the presence of this
metallic implant .
For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation . The MedicAlert Foundation can be
contacted in the following manners:
Mail:
MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone:
888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www .medicalert .org
11.5 Additional Surveillance and Treatment
Additional surveillance and possible treatment is recommended for:
• Aneurysms with Type I endoleak
• Aneurysms with Type III endoleak
• Aneurysm enlargement, ≥5 mm of maximum diameter (regardless of
endoleak status)
• Migration
• Inadequate seal length
Consideration for reintervention or conversion to open repair should
include the attending physician’s assessment of an individual patient’s
comorbidities, life expectancy and the patient’s personal choices . Patients
should be counseled that subsequent reinterventions, including catheter
based and open surgical conversion are possible following endograft
placement .
12 MAIN BODY RELEASE TROUBLESHOOTING
NOTE:
Technical assistance from a Cook product specialist may be obtained
by contacting your local Cook representative .
NOTE:
In case of difficulty removing the bare stent wires from the
graft during rotation of the blue handle, proceed through the normal
deployment process of the ipsilateral limb release . If this still does not
alleviate difficulty, proceed with the main body release troubleshooting
steps below to disassemble the rotation handle .
NOTE:
In case of difficulty with ipsilateral limb release, proceed directly to
steps 1-4 below .
1 . Place surgical forceps into the slots on the back-end clips and slide both
clips out . (
Fig 44 and 45
)
2 . Remove the back-end cap from the blue rotation handle . (
Fig 46
)
3 . While holding the black gripper, remove the blue rotation handle by
sliding it straight back . (
Fig . 47
) The trigger wires will be visible . (
Fig . 48
)
NOTE:
Tension will be felt during the removal of the rotation handle .
NOTE:
If the blue rotation handle feels as though it can not be removed,
turn the blue rotation handle in the opposite direction of the white arrow
(counterclockwise) and continue until the handle has been completely
removed .
NOTE:
The handle is designed such that any and all failures will not impede
rotation of the blue handle and removal of the trigger wires .
4 . Using forceps, grasp all the wires and withdraw them until the graft is
released . (
Fig 49
)
11 .2 .1 Acceptable Imaging Protocols
Non-Contrast
Contrast
IV contrast
No
Yes
Acceptable machines
Spiral CT or high performance MDCT capable
of >40 seconds
Spiral CT or high performance MDCT capable
of >40 seconds
Injection volume
n/a
Per institutional protocol
Injection rate
n/a
>2 .5 cc/sec
Injection mode
n/a
Power
Bolus timing
n/a
Test bolus: SmartPrep, C .A .R .E . or equivalent
Coverage – start
Diaphragm
1 cm superior to celiac axis
Coverage – finish
Proximal femur
Profunda femoris origin
Collimation
<3 mm
<3 mm
Reconstruction
2 .5 mm throughout – soft algorithm
2 .5 mm throughout – soft algorithm
Axial DFOV
32 cm
32 cm
Post-injection runs
None
None
