Femoral-To-Femoral Crossover; Imaging Guidelines And Postoperative Follow-Up; General; Mri Information - COOK Medical Zenith Instrucciones De Uso

1 . Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline .
• Remove all air from balloon .
2 . In preparation for insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise .
3 . Re-introduce the J tip wire guide . Advance the wire guide until it curves
inside the body of the iliac plug . Advance the molding balloon over the
wire guide and through the hemostatic valve into the iliac plug .
CAUTION: Do not inflate balloon in vessel outside of graft.
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure, by turning it clockwise .
5 . Expand the molding balloon within the iliac plug using diluted contrast
media (as directed by the manufacturer) . (Fig. 34)
CAUTION: Confirm complete deflation of balloon prior to repositioning.
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
the molding balloon.
6 . Completely deflate and remove molding balloon, replace it with an
angiographic catheter and perform completion angiograms to verify
proper occlusion of the appropriate common iliac artery .

Femoral-to-Femoral Crossover

Perform femoral-to-femoral crossover in standard surgical fashion to
revascularize the contralateral limb . Repair vessels and close in standard
surgical fashion .

12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP

For information on imaging guidelines and postoperative follow-up, please
refer to the Zenith Flex AAA Endovascular Graft Instructions for Use . A copy is
available online at www .cookmedical .com .

12.1 General

• The long-term performance of endovascular grafts with secondary
endovascular intervention using additional components has not yet
been established. All patients 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, enlarging aneurysms or changes in the
structure or position of the endovascular graft) should receive additional
follow-up . Patients should be counseled on the importance of adhering to
the follow-up schedule, both during the first year and at yearly intervals
thereafter . Patients should be told that regular and consistent follow-up is a
critical part of ensuring the ongoing safety and effectiveness of
endovascular treatment of AAAs .
• Physicians should evaluate patients on an individual basis and prescribe
follow-up relative to the needs and circumstances of each individual patient .
The minimum requirement for patient follow-up (described in the
Instructions for Use for the Zenith Flex AAA Endovascular Graft) should be
maintained even in the absence of clinical symptoms (e .g ., pain, numbness,
weakness) . Patients with specific clinical findings (e .g ., endoleaks, enlarging
aneurysms or changes in the structure or position of the stent graft) should
receive follow-up at more frequent intervals .
• Annual imaging follow-up should include abdominal radiographs and both
contrast and non-contrast CT examinations . If renal complications or other
factors preclude the use of image contrast media, abdominal radiographs,
non-contrast CT and duplex ultrasound may be used .
• The combination of contrast and non-contrast CT imaging provides
information on aneurysm diameter change, endoleak, patency, tortuosity,
progressive disease, fixation length and other morphological changes .
• The abdominal radiographs provide information on device integrity (e .g .,
separation between components, stent fracture) .
• Duplex ultrasound imaging may provide information on aneurysm diameter
change, endoleak, patency, tortuosity and progressive disease . In this
circumstance, a non-contrast CT should be performed to use in conjunction
with the ultrasound . Ultrasound may be a less reliable and sensitive
diagnostic method compared to CT .
• The minimum imaging follow-up for patients with Zenith AAA stent grafts is
described in the Instructions for Use for the Zenith (Flex) AAA Endovascular
Graft, which can be found at www .cookmedical .com . Patients requiring
enhanced follow-up should have interim evaluations .

12.2 MRI Information

The MR safety and compatibility of the Zenith AAA Ancillary Components is
based upon MR safety and compatibility of the Zenith AAA Endovascular
Graft, which is made from stents of the same metal .
Non-clinical testing has demonstrated that the Zenith AAA 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 .
• Highest spatial magnetic gradient field of 720 Gauss/cm
Non-clinical evaluation was conducted in a 3 Tesla MR system (General
Electric Excite) with a maximum spatial magnetic gradient field of
720 Gauss/cm as measured with a gaussmeter in the position of the static
magnetic field pertinent to the patient (i .e ., outside of scanner covering,
accessible to a patient or individual) .

MRI-Related Heating

1.5 Tesla Systems:
• Static magnetic field of 1 .5 Tesla
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 .0 W/kg
for 15 minutes of scanning (i .e ., per scanning sequence)
In non-clinical testing, the Zenith AAA Endovascular Graft produced a
temperature rise of less than or equal to 1 .4 °C at a MRI system reported
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 measured value of 1 .5 W/kg .
3.0 Telsa Systems
• Static magnetic field of 3 .0 Tesla
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 .0 W/kg
for 15 minutes of scanning (i .e ., per scanning sequence)
In non-clinical testing, the Zenith AAA Endovascular Graft produced a
temperature rise of less than or equal to 1 .9 °C at a MR system reported
whole-body-averaged specific absorption rate (SAR) of 3 .0 W/kg, for 15
minutes of MR scanning in a 3 .0 Tesla Excite, GE Electric Healthcare, G3 .0-052B
Software, MR Scanner . The maximum whole-body-averaged 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 anatomical 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 non-clinical testing using the sequence: 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 interest 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 extremities, 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 adverse
events or device problems in any of these patients as a result of having
received an MRI . Additionally, there have been well over 100,000 Zenith AAA
Endovascular Grafts implanted worldwide, in which there have been no
reported adverse events or device problems as a result of MRI .
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

12.3 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 co-morbidities,
life expectancy and the patient's personal choices . Patients should be
counseled that the need for subsequent reinterventions, including catheter-
based and open surgical conversion, are possible following endograft
placement .

13 PATIENT TRACKING INFORMATION

In addition to these Instructions for Use, the Zenith AAA Ancillary
Components with their respective introduction systems are packaged with a
Device Tracking Form, which the hospital staff is required to complete and
forward to Cook for the purposes of tracking all patients who receive the
Zenith AAA Ancillary Components (as required by U .S . Federal Regulation) .
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