27
confirm proper operation of the delivery system components, proper
placement of the graft, and desired procedural outcome .
• The use of the Zenith Alpha Abdominal Endovascular Graft 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• As the sheath and/or wire guide is withdrawn, anatomy and graft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 .
• The Zenith Alpha Abdominal Endovascular Graft incorporates a
suprarenal stent with fixation barbs . Exercise extreme caution when
manipulating interventional and angiographic devices in the region of
the suprarenal stent .
• 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 .
• Avoid damaging the graft or disturbing graft positioning after placement
in the event reinstrumentation (secondary intervention) of the graft is
necessary .
• Before deployment of the suprarenal stent, verify that the position of the
access wire guide extends just distal to the aortic arch .
• 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 vessel outside of the graft, as doing so
may cause damage to the vessel . Use the balloon in accordance with its
labeling .
• Use care when 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 .
Main Body Extension and Converter
• Care should be taken not to displace the main body graft during the
placement and deployment of the main body extension or converter .
• 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 .
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 Low Profile AAA
Endovascular Graft (The Zenith Low Profile AAA Endovascular Graft served
as a surrogate for the Zenith Alpha Abdominal Endovascular Graft) is MR
Conditional . A patient with this endovascular graft can be scanned safely
immediately after placement under the following conditions:
Static Magnetic Field
• Static magnetic field of 3.0 Tesla or less.
• Spatial magnetic gradient field of 1580 Gauss/cm (15.8 T/m) or less.
• The product of the spatial gradient and static magnetic field should not
exceed 47 .4 T2/m .
The static magnetic field for comparison to the above limits is the static
magnetic field that is pertinent to the patient (i .e ., outside of scanner
covering, accessible to a patient or individual) .
MRI-Related Heating
1 .5 and 3 .0 Tesla Systems: Maximum whole-body-averaged specific
absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i .e ., per
scanning sequence) .
1.5 Tesla Temperature Rise
In nonclinical testing, the Zenith Low Profile AAA Endovascular Graft
(The Zenith Low Profile AAA Endovascular Graft served as a surrogate for
the Zenith Alpha Abdominal Endovascular Graft) produced a maximum
temperature rise of 1 .7 °C during 15 minutes of MR imaging (i .e ., for one
scanning sequence) performed in a MR 1 .5 Tesla System (Magnetom,
Siemens Medical Solutions, Malvern, PA, Software Numaris/4) at an MR
system reported whole-body-averaged SAR of 2 .9 W/kg (associated with a
calorimetry measured whole-body-averaged value of 2 .1 W/kg) .
3.0 Tesla Temperature Rise
In nonclinical testing, the Zenith Low Profile AAA Endovascular Graft
(The Zenith Low Profile AAA Endovascular Graft served as a surrogate for
the Zenith Alpha Abdominal Endovascular Graft) produced a maximum
temperature rise of 2 .0 °C during 15 minutes of MR imaging (i .e ., for
one scanning sequence) performed in a MR 3 .0 Tesla System (Excite, GE
Healthcare, Milwaukee, WI, Software G3 .0-052B) at an MR system reported
whole-body-averaged SAR of 3 .0 W/kg (associated with a calorimetry
measured whole-body-averaged value of 2 .8 W/kg) .
Image Artifact
MR image quality may be compromised if the area of interest is within the
lumen or within approximately 5 mm of the position of the Zenith Alpha
Abdominal Endovascular Graft, as found during nonclinical testing using
the sequences: T1-weighted spin echo and gradient echo pulse in a 3 .0
Tesla MR system (Excite, General Electric Healthcare) . Therefore, it may be
necessary to optimize MR imaging parameters for the presence of this
metallic implant .
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 POTENTIAL ADVERSE EVENTS
Adverse events associated with either the Zenith Alpha Abdominal
Endovascular Graft or the implantation procedure 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; suture break; occlusion;
infection; stent fracture; graft material wear; dilatation; erosion; puncture;
perigraft flow; barb separation and corrosion; component separation
• 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 Alpha Abdominal
Endovascular Graft 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 .
6 PATIENT SELECTION AND TREATMENT
(Refer to
Section 4, WARNINGS AND PRECAUTIONS
)
6.1 Individualization of Treatment
Cook recommends that the Zenith Alpha Abdominal Endovascular Graft
component diameters be selected as described in
Tables 9 .5 .1, 9 .5 .2, 9 .5 .3
and
9 .5 .4
within
Section 9, CLINICAL USE INFORMATION
. The length
of the Zenith Alpha Abdominal Endovascular Graft should extend from
the lowest renal artery to just above the internal iliac (hypogastric) artery
bifurcation . All lengths and diameters of the devices necessary to complete
the procedure should be available to the physician, especially when
preoperative case planning measurements (treatment diameters/lengths)
are not certain . This approach allows for greater intraoperative flexibility to
achieve optimal procedural outcomes . Additional considerations for patient
selection include, but are not limited to:
• Patient’s age and life expectancy
• Comorbidities (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 Alpha Abdominal Endovascular Graft
• Patient's ability to tolerate general, regional or local anesthesia
• lIiofemoral access vessel size and morphology (minimal thrombus,
calcification and/or tortuosity) should be compatible with a 16 French
(6 .0 mm OD) or 17 French (6 .5 mm OD) vascular introducer sheath .
• Non-aneurysmal infrarenal aortic segment (neck) proximal to the
aneurysm:
• with a length of at least 15 mm,
•
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
