Patient Counseling Information; How Supplied; Clinical Use Information; Physician Training - COOK Medical Zenith Instrucciones De Uso

measurements (treatment diameters/lengths) are not certain . This approach
allows for greater intraoperative flexibility to achieve optimal procedural
outcomes . The risks and benefits should be carefully considered for each
patient before use of the Zenith AAA Ancillary Components . Additional
considerations for patient selection include, but are not limited to:
• Patient's age and life expectancy .
• Co-morbidities (e .g ., cardiac, pulmonary or renal insufficiency prior to
surgery, morbid obesity) .
• Patient's suitability for open surgical repair .
• Patient's anatomical suitability for endovascular repair .
• The risk of aneurysm rupture compared to the risk of treatment with the
Zenith AAA Ancillary Components .
• Patient's ability to tolerate general, regional or local anesthesia .
• Iliofemoral access vessel size and morphology (minimal thrombus,
calcification and/or tortuosity) should be compatible with vascular access
techniques and accessories of the delivery profile of a 14 French to
20 French vascular introducer sheath .
• For main body extension, non-aneurysmal infrarenal aortic segment (neck)
proximal to the aneurysm:
• with a diameter measured outer wall to outer wall of no greater than
32 mm and no less than 18 mm,
• with an angle less than 60 degrees relative to the long axis of the
aneurysm, and
• with an angle less than 45 degrees relative to the axis of the suprarenal
aorta .
• Iliac artery distal fixation site greater than 10 mm in length and 7 .5 to 20 mm
in diameter (measured outer wall to outer wall) .
• Freedom from significant femoral/iliac artery occlusive disease that would
impede flow through the endovascular graft .
The final treatment decision is at the discretion of the physician and patient .

8 PATIENT COUNSELING INFORMATION

The physician and patient (and/or family members) should review the risks
and benefits when discussing this endovascular device and procedure,
including:
• Risks and differences between endovascular repair and surgical repair .
• Potential advantages of traditional open surgical repair .
• Potential advantages of endovascular repair .
• The possibility that subsequent interventional or open surgical repair of the
aneurysm may be required after initial endovascular repair .
In addition to the risks and benefits of an endovascular repair, the physician
should assess the patient's commitment and compliance to postoperative
follow-up as necessary to ensure continuing safe and effective results . Listed
below are additional topics to discuss with the patient as to expectations
after an endovascular repair:
• The long-term performance of endovascular grafts 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 enhanced follow-up .
Specific follow-up guidelines are described in Section 12, IMAGING
GUIDELINES AND POSTOPERATIVE 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 . At a minimum, annual imaging and adherence to routine
postoperative follow-up requirements are required and should be
considered a life-long commitment to the patient's health and well-being .
• The patient should be told that successful aneurysm repair does not arrest
the disease process . It is still possible to have associated degeneration of
vessels .
• Physicians must advise each patient that it is important to seek prompt
medical attention if he/she experiences signs of limb occlusion, aneurysm
enlargement or rupture . Signs of graft limb occlusion include pain in the
hip(s) or leg(s) during walking or at rest or discoloration or coolness of the
leg . Aneurysm rupture may be asymptomatic, but usually presents as: pain;
numbness; weakness in the legs; any back, chest, abdominal or groin pain;
dizziness; fainting; rapid heartbeat or sudden weakness .
• Due to the imaging required for successful placement and follow-up of
endovascular devices, the risks of radiation exposure to developing tissue
should be discussed with women who are or suspect they are pregnant .
• Men who undergo endovascular or open surgical repair may experience
impotence .
Physicians should refer the patient to the Patient Guide regarding risks
occurring during or after implantation of the device . Procedure-related risks
include cardiac, pulmonary, neurologic, bowel and bleeding complications .
Device-related risks include occlusion, endoleak, aneurysm enlargement,
fracture, potential for reintervention and open surgical conversion, rupture
and death (See Section 5, ADVERSE EVENTS) . The physician should
complete the Patient I .D . Card and give it to the patient so that he/she can
carry it with him/her at all times . The patient should refer to the card anytime
he/she visits additional health practitioners, particularly for any additional
diagnostic procedures (e .g ., MRI) .

9 HOW SUPPLIED

• The Zenith AAA Ancillary Components are sterilized by ethylene oxide gas,
pre-loaded into the Z-Trak Introduction System, and supplied in peel-open
packages .
• The devices are intended for one-time use only . Do not re-sterilize the
devices .
• The product is sterile if the package is unopened and undamaged . Inspect
the device and packaging to verify that no damage has occurred as a result
of shipping . Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken . If damage has occurred,
do not use the product and return to Cook .
• Prior to use, verify correct devices (quantity and size) have been supplied for
the patient by matching the device to the order prescribed by the physician
for that particular patient .
• Do not use after the "USE BY" (expiration) date printed on the label .
• Store in a cool, dry place .

10 CLINICAL USE INFORMATION

10.1 Physician Training

CAUTION: Always have a qualified surgery team available during
implantation or re-intervention procedures in the event that conversion
to open surgical repair is necessary.
CAUTION: The Zenith AAA Ancillary Components with the Z-Trak
Introduction Systems should only be used by physicians and teams
trained in vascular interventional techniques and in the use of this
device. The recommended skill/knowledge requirements for physicians
using the Zenith AAA Ancillary Components with the Z-Trak Introduction
System are outlined below:
Patient selection:
• Knowledge of the natural history of abdominal aortic aneurysms (AAA) and
co-morbidities associated with AAA repair .
• Knowledge of radiographic image interpretation, device selection, planning
and sizing .
A multidisciplinary team that has combined procedural experience with:
• Femoral cutdown, arteriotomy and repair
• Percutaneous access and closure techniques
• Non-selective and selective wire guide and catheter techniques
• Fluoroscopic and angiographic image interpretation
• Embolization
• Angioplasty
• Endovascular stent placement
• Snare techniques
• Appropriate use of radiographic contrast material
• Techniques to minimize radiation exposure
• Expertise in necessary patient follow-up modalities

10.2 Inspection Prior to Use

Inspect the device and packaging to verify that no damage has occurred as a
result of shipping . Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken . If damage has occurred, do
not use the product and return to Cook . Prior to use, verify correct devices
(quantity and size) have been supplied for the patient by matching the device
to the order prescribed by the physician for that particular patient .

10.3 Materials Required

• Fluoroscope with digital angiography capabilities (C-arm or fixed unit)
• Contrast media
• Syringe
• Heparinized saline solution
• Sterile gauze pads

10.4 Materials Recommended

The following products are recommended . For information on the use of
these products, refer to the individual product's instructions for use .
• .035 inch (0 .89 mm) extra stiff wire guide, 260 cm; for example:
• Cook Amplatz Ultra Stiff Wire Guides (AUS2)
• Cook Lunderquist Extra Stiff Wire Guides (LES)
• .035 inch (0 .89 mm) standard wire guide; for example:
• Cook .035 inch wire guides
• Cook Nimble™ Wire Guides
• Molding Balloons; for example:
• Cook Coda Balloon Catheter
• Introducer sets; for example:
• Cook Check-Flo® Introducer Sets
• Cook Extra Large Check-Flo Introducer Sets
• Cook Flexor® Balkin Up & Over® Contralateral Introducers
• Sizing catheter; for example:
• Cook Aurous® Centimeter Sizing Catheters
• Angiographic radiopaque tip catheters; for example:
• Cook Beacon® Tip Angiographic Catheters
• Cook Beacon Tip Royal Flush Catheters
• Entry needles; for example:
• Cook single wall entry needles
• Endovascular Dilators; for example:
• Cook Endovasular Dilator Sets

10.5 Device Diameter Sizing Guidelines

The choice of diameter should be determined from the outer wall to outer
wall vessel diameter and not the lumen diameter . Undersizing or oversizing
may result in incomplete sealing or compromised flow .
Table 10.5.1 Main Body Extension Graft Diameter Sizing Guide*
Intended Main Body
Aortic Vessel Extension
Diameter 1,2 Diameter
(mm) (mm)
18-19
20-21
22-23
24-25
26-27
28
29-32
1
Maximum diameter along the proximal fixation site .
2
Round measured aortic diameter to nearest mm .
3
Additional considerations may affect choice of diameter .
*All dimensions are nominal .
Table 10.5.2 Flex Iliac Leg Graft Diameter Sizing Guide*
Intended
Iliac Leg
Iliac Vessel
Diameter
Diameter 1,2
(mm)
(mm)
<8 8
8-9 10
10-11 12
12-13 14
14-15 16
16-17 18
18 20
19 22
20 24
1
Maximum diameter along the distal fixation site .
2
Round measured iliac diameter to nearest mm .
3
Additional considerations may affect choice of diameter .
4
Overall leg length = working length + 22 mm docking stent .
*All dimensions are nominal .
22
Main Body
Extension
3 Length
(mm)
22 39, 58
24 39, 58
26 39, 58
28 39, 58
30 39, 58
32 39, 58
36 50, 73
Iliac Leg
3 Working Length 4
(mm)
37, 54, 71, 88, 105, 122
37, 54, 71, 88, 105, 122
39, 56, 73, 90, 107, 124
39, 56, 73, 90, 107, 124
39, 56, 73, 90
39, 56, 73, 90
39, 56, 73, 90
39, 56, 73, 90
39, 56, 73, 90
Introducer
Sheath
(Fr)
18
18
18
20
20
20
20
Introducer
Sheath
(Fr)
14
14
16
16
16
16
16
16
16