Device Selection; Implant Procedure; Molding Balloon Use; Mri Information - COOK Medical Zenith alpha Spiral-Z Mode D'emploi

components . These reconstructions should be performed in sagittal, coronal,
and 3-D .
• The long-term performance of this endovascular graft 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 aneurysm or changes in the
structure or position of the endovascular graft) should receive enhanced
follow-up . Specific follow-up guidelines are described in Section 11,
IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP .
• The Zenith Alpha Spiral-Z Endovascular Leg is not recommended in
patients unable to undergo, or who will not be compliant with, the
necessary preoperative and postoperative imaging and implantation
studies as described in Section 11, IMAGING GUIDELINES AND
POSTOPERATIVE FOLLOW-UP .
• After endovascular graft placement, patients should be regularly
monitored for perigraft flow, aneurysm growth or changes in the
structure or position of the endovascular graft . At a minimum, annual
imaging is required, including: 1) abdominal radiographs to examine
device integrity (separation between components or stent fracture) and
2) contrast and non-contrast CT to examine aneurysm changes, perigraft
flow, patency, tortuosity and progressive disease . If renal complications
or other factors preclude the use of image contrast media, abdominal
radiographs and duplex ultrasound may provide similar information .

4.4 Device Selection

• Strict adherence to the Zenith Alpha Spiral-Z Endovascular Leg IFU sizing
guide is strongly recommended when selecting the appropriate device
size (Table 9 .5 .1) . Appropriate device oversizing has been incorporated
into the IFU sizing guide . Sizing outside of this range can result in
endoleak, fracture, migration, device infolding or compression .

4.5 Implant Procedure

(Refer to Section 10, DIRECTIONS FOR USE)
• Appropriate procedural imaging is required to successfully position the
Zenith Alpha Spiral-Z Endovascular Leg and assure accurate apposition to
the vessel wall .
• Do not bend or kink the delivery system . Doing so may cause damage to
the delivery system and the Zenith Alpha Spiral-Z Endovascular Leg Graft .
• To avoid any twist in the endovascular graft, during any rotation of
the delivery system, be careful to rotate all components of the system
together (from outer sheath to inner cannula) .
• To avoid damage to the sheath, be careful to advance all components of
the system together (from outer sheath to inner cannula) .
• Do not continue advancing any portion of the delivery system if
resistance is felt during advancement of the wire guide or delivery system .
Stop and assess the cause of resistance; vessel, catheter or graft damage
may occur . Exercise particular care in areas of stenosis, intravascular
thrombosis, or in calcified or tortuous vessels .
• Inadvertent partial deployment or migration of the endoprosthesis may
require surgical removal .
• Unless medically indicated, do not deploy the Zenith Alpha Spiral-Z
Endovascular Leg in a location that will occlude arteries necessary to
supply blood flow to organs or extremities .
• Do not attempt to re-sheath the graft after partial or complete
deployment .
• Inaccurate placement and/or incomplete sealing of the Zenith Alpha
Spiral-Z Endovascular Leg within the vessel may result in increased risk of
endoleak, migration or inadvertent occlusion of the internal iliac arteries .
• Inadequate overlap of the Zenith Alpha Spiral-Z Endovascular Leg with
the main body graft may result in increased risk of migration of the stent
graft . Incorrect deployment or migration of the endoprosthesis may
require surgical intervention .
• Systemic anticoagulation should be used during the implant procedure
based on hospital- and physician-preferred protocol . If heparin is
contraindicated, an alternative anticoagulant should be considered .
• To activate the hydrophilic coating on the outside of the Flexor
introducer sheath, the surface must be wiped with sterile gauze pads
soaked in saline solution . Always keep the sheath hydrated for optimal
performance .
• Minimize handling of the constrained endoprosthesis during preparation
and insertion to decrease the risk of endoprosthesis contamination and
infection .
• Maintain wire guide position during delivery system insertion .
• Fluoroscopy should be used during introduction and deployment to
confirm proper operation of the delivery system components, proper
placement of the graft, and desired procedural outcome .
• The use of the Zenith Alpha Spiral-Z Endovascular Leg requires
administration of intravascular contrast . Patients with pre-existing renal
insufficiency may have an increased risk of renal failure postoperatively .
Care should be taken to limit the amount of contrast media used during
the procedure and to observe preventative methods of treatment to
decrease renal compromise .
• As the sheath and/or wire guide is withdrawn, anatomy and graft position
may change . Constantly monitor graft position and perform angiography
to check position as necessary .
• Use caution during manipulation of catheters, wires and sheaths
within an aneurysm . Significant disturbances may dislodge fragments
of thrombus, which can cause distal embolization, or may rupture the
aneurysm .
• Avoid damaging the graft or disturbing graft positioning after placement
in the event reinstrumentation (secondary intervention) of the graft is
necessary .
• Excessive overlap of 12 mm above the main body graft bifurcation may
increase the risk of limb thrombosis .

4.6 Molding Balloon Use

• Do not inflate the balloon in the vessel outside of the graft, as doing so
may cause damage to the vessel . Use the balloon in accordance with its
labeling .
• Use care in inflating the balloon within the graft in the presence of
calcification, as excessive inflation may cause damage to the vessel .
• Confirm complete deflation of the balloon prior to repositioning .
• For added hemostasis, the Captor Hemostatic Valve can be loosened or
tightened to accommodate the insertion and subsequent withdrawal of
a molding balloon .

4.7 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 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

5 ADVERSE EVENTS

5.1 Potential Adverse Events

Adverse events that may occur and/or require intervention include:
• Amputation
• Anesthetic complications and subsequent attendant problems (e .g .,
aspiration)
• Aneurysm enlargement
• Aneurysm rupture and death
• Aortic damage, including perforation, dissection, bleeding, rupture and
death
• Aortic fistulation to adjacent organs/anatomic structures
• Arterial or venous thrombosis and/or pseudoaneurysm
• Arteriovenous fistula
• Bleeding, hematoma or coagulopathy
• Bowel complications (e .g ., ileus, transient ischemia, infarction, necrosis)
• Cardiac complications and subsequent attendant problems (e .g .,
arrhythmia, myocardial infarction, congestive heart failure, hypotension,
hypertension)
• Claudication (e .g ., buttock, lower limb)
• Death
• Edema
• Embolization (micro and macro) with transient or permanent ischemia or
infarction
• Endoleak
• Endoprosthesis: improper component placement; incomplete component
deployment; component migration; component separation from another
graft component; suture break; occlusion; infection; stent fracture; graft
material wear; dilatation; erosion; puncture; perigraft flow; and corrosion
• Fever and localized inflammation
• Genitourinary complications and subsequent attendant problems (e .g .,
ischemia, erosion, fistula, incontinence, hematuria, infection)
• Graft or native vessel occlusion
• Hepatic failure
• Impotence
• Infection of the aneurysm, device or access site, including abscess
formation, transient fever and pain
• Limb stenosis
• Lymphatic complications and subsequent attendant problems (e .g .,
lymph fistula)
• Neurologic local or systemic complications and subsequent attendant
problems (e .g ., stroke, transient ischemic attack, paraplegia, paraparesis,
paralysis)
• Pulmonary/respiratory complications and subsequent attendant
problems (e .g ., pneumonia, respiratory failure, prolonged intubation)
• Radiation injury and/or late malignancy
• Renal complications and subsequent attendant problems (e .g ., artery
occlusion, contrast toxicity, insufficiency, failure)
• Surgical conversion to open repair
• Vascular access site complications, including infection, pain, hematoma,
pseudoaneurysm, arteriovenous fistula
• Vessel damage
• Wound complications and subsequent attendant problems (e .g .,
dehiscence, infection)
• Vascular spasm or vascular trauma (e .g ., iliofemoral vessel dissection,
bleeding, rupture, death)

Device-Related Adverse Event Reporting

Any adverse event (clinical incident) involving the Zenith Alpha Spiral-Z
Endovascular Leg should be reported to Cook immediately . For customers
inside the United States, to report an incident, call the Customer Relations
Department at 1-800-457-4500 (24 hour) or 1-812-339-2235 . For customers
outside the United States, please call your distributor .
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