Molding Balloon Use; Mri Information; Potential Adverse Events; Patient Selection And Treatment - COOK Medical Zenith Alpha Gebrauchsanweisung

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• As the sheath and/or wire guide is withdrawn, anatomy and graft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 T 2 /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
27