20
9 . Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation site and expand . (Fig . 14)
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
10 . Remove molding balloon and replace it with an angiographic catheter
to perform completion angiograms .
11 . Remove or replace all stiff wire guides to allow iliac arteries to resume
their natural position .
Final Angiogram
1 . Position angiographic catheter just above the level of the renal arteries .
Perform angiography to verify that the renal arteries are patent and that
there are no endoleaks . Verify patency of internal iliac arteries .
2 . Confirm there are no endoleaks or kinks and verify position of proximal
gold radiopaque markers . Remove the sheaths, wires and catheters .
NOTE: If endoleaks or other problems are observed, refer to the
Suggested Instructions for Use for the Zenith AAA Endovascular Graft
Ancillary Components .
3 . 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 Instructions for Use for the Zenith AAA main body or Renu that
was used . 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
lifelong, 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 AAA main body or Renu that was used)
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 AAA main body
or Renu that was used, which can be found at www .cookmedical .com .
Patients requiring enhanced follow-up should have interim evaluations .
12.2 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 .
12.3 MRI Information
Non-clinical testing has demonstrated that the Zenith Spiral-Z AAA Iliac
Leg Graft is MR Conditional . It 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 W/kg
for 15 minutes of scanning ( i .e ., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2 .1 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2 .9 W/kg, for 15 minutes of MR
scanning in a 1 .5 Tesla, Siemens Medical Magnetom, Numaris/4 Software,
Version Syngo MR 2002B DHHS MR Scanner . The maximum whole-body-
averaged specific absorption rate (SAR) was 2 .9 W/kg, which corresponds to
a calorimetry measured value of 2 .1 W/kg .
3.0 Tesla Systems:
• Static magnetic field of 3.0 Tesla
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg
for 15 minutes of scanning( i .e ., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2 .6 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2 .9 W/kg, for 15 minutes of MR
scanning in a 3 .0 Tesla Excite, GE Electric Healthcare, 14X .M5 Software, MR
Scanner . The maximum whole-body-averaged specific absorption rate (SAR)
was 2 .9 W/kg, which corresponds to a calorimetry measured value of 2 .7 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 5 cm of the device, as well as the entire device and its
lumen, when scanned in nonclinical 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, depending on distance from the
device to the area of interest .
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
13 PATIENT TRACKINg INFORMATION
In addition to these Instructions for Use, the Zenith Spiral-Z AAA Iliac Leg
with the Z-Trak Introduction System is 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 Spiral-Z AAA
Iliac Leg (as required by U .S . Federal Regulation) .
