Device Selection; Implant Procedure; Molding Balloon Use; Main Body Extension - COOK Medical Zenith Instrucciones De Uso

• The Zenith AAA Ancillary Components with the Z-Trak Introduction System
are 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 the Zenith (Flex) AAA Endovascular
Graft Instructions for Use . A copy is available online at www .cookmedical .
com .
• 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 AAA Endovascular Graft Ancillary Components
IFU sizing guide is strongly recommended when selecting the appropriate
device size (Tables 10.5.1 through 10.5.6) . 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 11, DIRECTIONS FOR USE)
• Appropriate procedural imaging is required to successfully position the
Zenith AAA Ancillary Components and assure accurate apposition to the
aortic wall .
• Do not bend or kink the delivery system . Doing so may cause damage to the
delivery system and the Zenith AAA Ancillary Component .
• 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) .
• 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 AAA Ancillary
Components in a location that will occlude arteries necessary to supply
blood flow to organs or extremities . Do not cover significant renal or
mesenteric arteries (exception is the inferior mesenteric artery) with the
endoprosthesis . Vessel occlusion may occur . During the clinical study this
device was not studied in patients with two occluded internal iliac arteries .
• Do not attempt to re-sheath the graft after partial or complete deployment .
• Repositioning the stent graft distally after partial deployment of the covered
proximal stent may result in damage to the stent graft and/or vessel injury .
• Inaccurate placement and/or incomplete sealing of the Zenith AAA Ancillary
Components within the vessel may result in increased risk of endoleak,
migration or inadvertent occlusion of the renal or internal iliac arteries .
Renal artery patency must be maintained to prevent/reduce the risk of renal
failure and subsequent complications .
• Inadequate fixation of the Zenith AAA Ancillary Components 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 implantation procedure
based on hospital and physician preferred protocol . If heparin is
contraindicated, an alternative anticoagulant should be considered .
• 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 .
• Always use fluoroscopy for guidance, delivery and observation of any Zenith
AAA Ancillary Component within the vasculature .
• The use of the Zenith AAA Ancillary Components with the Z-Trak
Introduction System requires administration of intravascular contrast .
Patients with preexisting 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 (e .g ., adequate
hydration) .
• 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 rupture of the aneurysm .
• Care should be taken not to displace or damage the main body graft during
placement and deployment .
• The converter and main body extension delivery systems cannot be
introduced through a main body or iliac leg introducer sheath .

4.6 Molding Balloon Use

• Do not inflate balloon in the vessel outside of 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 .

4.7 Main Body Extension

Care should be taken not to displace the main body graft during the
placement and deployment of the main body extension .

4.8 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 endovasular 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 MR 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 Tesla 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

5 ADVERSE EVENTS

5.1 Observed Adverse Events

For information on observed adverse events in patients receiving the Zenith
(Flex) AAA Endovascular Graft, some of whom received Zenith AAA Ancillary
Components, please refer to the Zenith (Flex) AAA Endovascular Graft
Instructions for Use . A copy is available online at www .cookmedical .com .

5.2 Potential Adverse Events

Adverse events that may occur and/or require intervention include, but are
not limited to:
• 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
• 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
• 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)
• 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
• Vascular spasm or vascular trauma (e .g ., iliofemoral vessel dissection,
bleeding, rupture, death)
• Vessel damage
• Wound complications and subsequent attendant problems (e .g ., dehiscence,
infection)

Device-Related Adverse Event Reporting

Any adverse event (clinical incident) involving the Zenith AAA Ancillary
Components should be reported to Cook immediately . 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 .

6 SUMMARY OF CLINICAL STUDIES

For clinical study information regarding patients receiving the Zenith (Flex)
AAA Endovascular Graft, some of whom received Zenith AAA Ancillary
Components, please refer to the Zenith (Flex) AAA Endovascular Graft
Instructions for Use . A copy is available online at www .cookmedical .com .

7 PATIENT SELECTION AND TREATMENT

(See Section 4, WARNINGS AND PRECAUTIONS)

7.1 Individualization of Treatment

Cook recommends that the Zenith AAA Ancillary Component diameters be
selected as described in Tables 10.5.1 through 10.5.6 . All lengths and
diameters of the devices necessary to complete the procedure should be
available to the physician, especially when preoperative case planning
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