Abdominal Radiographs; Mri Information; Static Magnetic Field; Additional Surveillance And Treatment - COOK Medical Zenith Alpha Mode D'emploi

IV contrast
Acceptable machines
Injection volume
Injection rate
Injection mode
Bolus timing
Coverage – start
Coverage – finish
Collimation
Reconstruction
Axial DFOV
Post-injection runs

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 Alpha Abdominal
Endovascular Graft used with Zenith Alpha Spiral-Z Endovascular Legs is
MR Conditional according to ASTM F2503 . A patient with this device may
be safely scanned under the following conditions .

Static Magnetic Field

• Static magnetic field of 3 .0 tesla or 1 .5 tesla only
• Maximum spatial magnetic gradient of 1600 gauss/cm (16 .0 T/m) or less
• Maximum MR system reported, whole-body-averaged specific
absorption rate (SAR) of ≤ 2 .0 W/kg (Normal Operating Mode) for 15
minutes of continuous scanning .
Under the scan conditions provided above, the Zenith Alpha Abdominal
Endovascular Graft used with Zenith Alpha Spiral-Z Endovascular Legs is
not expected to result in a temperature rise of more than 1 .3°C after 15
minutes of continuous scanning .
Image Artifact
The image artifact extends approximately 9 .5 mm from the Zenith
Alpha Abdominal Endovascular Graft used with Zenith Alpha Spiral-Z
Endovascular Legs as found during nonclinical testing when imaged with
a gradient echo pulse sequence and a 3 .0 Tesla MRI system . The image
artifact obscures the device lumen .
11 .2 .1 Acceptable Imaging Protocols
Non-Contrast
No
Spiral CT or high performance MDCT capable
of >40 seconds
n/a
n/a
n/a
n/a
Diaphragm
Proximal femur
<3 mm
2 .5 mm throughout – soft algorithm
32 cm
None
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:
Phone:
Web:

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 .
34
Spiral CT or high performance MDCT capable
Test bolus: SmartPrep, C .A .R .E . or equivalent
2 .5 mm throughout – soft algorithm
MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
www .medicalert .org
Contrast
Yes
of >40 seconds
Per institutional protocol
>2 .5 cc/sec
Power
1 cm superior to celiac axis
Profunda femoris origin
<3 mm
32 cm
None