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3 . Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral iliac leg graft . Advance the dilator and sheath assembly into
the main body sheath .
NOTE: In tortuous vessels, the position of the internal iliac arteries may
alter significantly with the introduction of the rigid wires and sheath
systems .
4 . Continue advancing slowly until the zone between the two proximal
gold markers aligns with the gold radiopaque marker at the bifurcation
of the main body graft . Closely align the proximal edge of the ipsilateral
leg graft with the proximal edge of the previously placed contralateral
leg graft . (Fig . 12 and 13)
NOTE: If this device is used in conjunction with a Zenith Flex main
body or Zenith Universal Distal body, advance the ipsilateral
leg graft until it is closely aligned with the previously placed
contralateral leg graft .
NOTE: For use with a Renu converter, ensure that the iliac leg overlaps
a minimum of two full iliac leg stents (i .e ., proximal stents of the iliac leg
graft) inside the Renu converter .
5 . Confirm position of the distal end of the iliac leg graft . Using the gold
markers as reference points, reposition the iliac leg graft if necessary to
ensure internal iliac patency .
6 . To deploy, hold the iliac leg graft in position with the gray positioner
while withdrawing the sheath approximately 10 mm . (Figs . 14 and 15)
7 . Check the graft position and reposition if necessary .
8 . Continue to deploy the graft by withdrawing the sheath while
continuously checking the position of the graft .
9 . Under fluoroscopy and after verification of iliac leg graft position,
loosen the pin vise, and retract the inner cannula to dock the tapered
dilator to the positioner . Tighten the pin vise . Maintain sheath position
while withdrawing the positioner with secured inner cannula . (Fig . 16)
10 . Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops . (Fig . 7)
11 . Re-check the position of the wire guides . Leave the sheath and wire
guides in place .
10.1.6 Molding Balloon Insertion
1 . Prepare the molding balloon as follows:
• Flush the wire lumen with heparinized saline .
• Remove all air from the balloon .
2 . In preparation for the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counter-clockwise .
3 . Advance the molding balloon over the wire guide and through the
Captor Hemostatic Valve of the main body introduction system to the
level of the renal arteries . Maintain proper sheath position .
4 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise .
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
5 . Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the most proximal covered stent
and the infrarenal neck, starting proximally and working in the distal
direction . (Fig . 17)
CAUTION: Confirm complete deflation of the balloon prior to
repositioning .
CAUTION: The Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
6 . Withdraw the molding balloon to the ipsilateral limb overlap region
and expand .
CAUTION: The Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
7 . Withdraw the molding balloon to the ipsilateral distal fixation site and
expand .
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
CAUTION: The Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
8 . Deflate and remove the molding balloon . Transfer the molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
introduction system . Advance the molding balloon to the contralateral
limb overlap and expand .
CAUTION: Confirm complete deflation of the balloon prior to
repositioning .
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
9 . Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation site and expand . (Fig . 17)
CAUTION: Do not inflate the balloon in the vessel outside of the
graft .
10 . Remove the 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 an 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 the
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 appropriate main body or Renu
IFU .
3 . Repair vessels and close in standard surgical fashion .
11 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 devices that were used . A copy
is available online at www .cookmedical .com .
11.1 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 device 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 .
• 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 .
11.2 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 .
11.3 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 .
MRI-Related Heating
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 .
For US Patients Only
Cook reccommends 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 PATIENT TRACKING INFORMATION
In addition to these Instructions for Use, the Zenith Alpha Spiral-Z
Endovascular Leg 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 Alpha Spiral-Z Endovascular
Leg (as required by U .S . Federal Regulation) .
13 REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature . Refer to your local Cook sales representative for
information on available literature .
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