Implant Procedure; Molding Balloon Use; Mri Safety And Compatibility; Potential Adverse Events - COOK Medical Zenith Fenestrated Mode D'emploi

• The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is not recommended in patients who cannot
tolerate contrast agents necessary for intra-operative and post-operative
follow-up imaging.
• The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is not recommended in patients exceeding weight
and/or size limits, which compromise or prevent the necessary imaging
requirements.
• The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot
Introduction System is not recommended in patients with known
sensitivities or allergies to stainless steel, polyester, nitinol, solder (tin,
silver), polypropylene or gold.
• Patients with a systemic infection may be at increased risk of
endovascular graft infection.
• Inability to maintain patency of at least one internal iliac artery or
occlusion of an indispensable inferior mesenteric artery may increase the
risk of pelvic/bowel ischemia.
• Multiple large, patent lumbar arteries, mural thrombus and a patent
inferior mesenteric artery may all predispose a patient to Type II
endoleaks. Patients with uncorrectable coagulopathy may also have an
increased risk of Type II endoleak or bleeding complications.

4.3 Implant Procedure

• 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.
• Minimise handling of the constrained endoprosthesis during preparation
and insertion to decrease the risk of endoprosthesis contamination and
infection.
• To activate the hydrophilic coating on the outside of the Flexor introducer
sheath, the surface must be wiped with 4x4 gauze pads soaked in saline
solution. Always keep the sheath hydrated for optimal performance.
• Maintain wire guide position during delivery system insertion.
• Do not bend or kink the delivery system. Doing so may cause damage to
the delivery system and the Zenith Fenestrated AAA Endovascular Graft.
• 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 Fenestrated AAA Endovascular Graft with the H&L-B
One-Shot Introduction System requires administration of intravascular
contrast.
Patients with pre-existing renal insufficiency may have an increased risk
of renal failure post-operatively. Care should be taken to limit the amount
of contrast media used during the procedure.
• To avoid any twist in the endovascular graft, during any rotation of the
delivery system, be careful to rotate all of the components of the system
together (from outer sheath to inner cannula).
• Inaccurate placement and/or incomplete sealing of the Zenith
Fenestrated AAA Endovascular Graft 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 Fenestrated AAA Endovascular Graft
may result in increased risk of migration of the stent graft.
Incorrect deployment or migration of the endoprosthesis may require
surgical intervention.
• The Zenith Fenestrated AAA Endovascular Graft incorporates a suprarenal
stent with fixation barbs.
Exercise extreme caution when manipulating interventional devices in
the region of the suprarenal stent.
• 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 or catheter damage may
occur. Exercise particular care in areas of stenosis, intravascular
thrombosis or in calcified or tortuous vessels.
• Unless medically indicated, do not deploy the Zenith Fenestrated AAA
Endovascular Graft 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 only
if the superior mesenteric artery and the anastomosis of Riolan are
patent and functioning correctly) with the endoprosthesis. Vessel
occlusion may occur. Clinical studies have identified that with use of the
Zenith Fenestrated AAA Endovascular Graft there is a risk of renal
impairment/loss (which could lead to a need for dialysis).
Clinical studies have shown that this risk is reduced when the renal
arteries are stented as part of the procedure to implant a Zenith
Fenestrated AAA Endovascular Graft.
Stenting of the renal arteries is therefore strongly recommended with
use of the Zenith Fenestrated AAA Endovascular Graft to reduce the risk
of renal impairment/loss.
• Take care during manipulation of catheters, wires and sheaths within an
aneurysm. Significant disturbances may dislodge fragments of thrombus,
which can cause distal embolisation.
• Before deployment of the suprarenal stent, verify that the position of the
access wire guide extends just distal to the aortic arch.
• Verify that the predetermined contralateral iliac leg is selected for
insertion on the contralateral side of the patient before implantation.
• Care should be taken not to damage the graft or disturb graft positioning
after graft placement in the event reinstrumentation of the graft is
necessary.

4.4 Molding Balloon Use

• Prior to molding in the vicinity of any fenestration stent(s) confirm that
the aortic section of the stent has been flared.
• Confirm complete deflation of balloon prior to repositioning.
• Do not inflate balloon in iliac vessel outside of graft.

4.5 MRI Safety and Compatibility

Non-clinical testing conducted on the standard Zenith AAA Endovascular
Graft has demonstrated that the graft is MR Conditional.
The Zenith Fenestrated AAA Graft contains the same metal as the standard
Zenith AAA device (stainless steel), but also contains a small amount of
nitinol. It is not expected that this small amount of Nitinol would alter the MRI
Conditional rating that was observed for the standard Zenith AAA device.
The standard Zenith AAA Endovascular Graft can be scanned safely under
the following conditions:
1.5 Tesla Systems:
• Static magnetic field strength of 1.5 Tesla
• Spatial gradient field of 450 Gauss/cm
• Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg
for 15 minutes of scanning
In non-clinical testing, the standard Zenith AAA Endovascular Graft
produced a temperature rise of less than or equal to 1.4°C at a maximum
whole body averaged speci c absorption rate (SAR) of 2.8 W/kg, as assessed
by calorimetry for 15 minutes of MR scanning in a 1.5 Tesla static magnetic
eld strength Magnetom, Siemens Medical Magnetom, Numaris/4
Software, Version Syngo MR 2002B DHHS MR Scanner. The maximum
whole body averaged speci c 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 strength of 3.0 Tesla
• Spatial gradient field of 720 Gauss/cm
• Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg
for 15 minutes of scanning
In non-clinical testing, the standard Zenith AAA Endovascular Graft
produced a temperature rise of less than or equal to 1.9°C at a maximum
whole body averaged speci c absorption rate (SAR) of 3.0 W/kg, as
assessed by calorimetry 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 speci c absorption rate (SAR) was 3.0 W/kg, which
corresponds to a calorimetry measured value of 2.8 W/kg.
MR image quality of the standard Zenith AAA Endovascular Graft may
be compromised if the area of interest is in the exact same area or within
approximately 20 cm of the device and its lumen, when scanned in
nonclinical testing using the sequence: Fast spin echo, in a 3.0 Tesla static
magnetic eld strength, Excite, GE Electric Healthcare, with G3.0-052B
software, MR system with body radiofrequency coil. Therefore it may be
necessary to optimize MR imaging parameters for this metallic implant.
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.
NOTE: For the Zenith Fenestrated AAA Graft, the clinical bene t of an MRI
scan should be balanced with the potential risk of the procedure.

5 POTENTIAL ADVERSE EVENTS

Use of the Zenith Fenestrated AAA Endovascular Graft poses the following
potential risks in addition to those associated with use of a standard Zenith
Endovascular Graft:
• Organ impairment/loss due to side-branch vessel occlusion (in particular,
renal and/or gastrointestinal impairment/loss).
Clinical studies have identi ed that with use of the Zenith Fenestrated AAA
Endovascular Graft there is a risk of renal impairment/loss (which could lead
to a need for dialysis). Clinical studies have shown that this risk is reduced
when the renal arteries are stented as part of the procedure to implant a
Zenith Fenestrated AAA Endovascular Graft.
Stenting of the renal arteries is therefore strongly recommended with use
of the Zenith Fenestrated AAA Endovascular Graft to reduce the risk of renal
impairment/loss.
Other 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
• Embolisation (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
• Fever and localised 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
• 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)

6 PATIENT SELECTION AND TREATMENT

(See Warnings and Precautions)

6.1 Individualisation of Treatment

Each patient must be evaluated on an individual basis with careful
consideration given to both the potential bene ts and speci c risks
associated with the procedure.
Considerations regarding the use of the Zenith Fenestrated AAA
Endovascular Graft (see Warnings and Precautions) include:
• Risk of aneurysm rupture
• Morbidity and mortality associated with conventional surgical repair
• Comorbidities
• Size of aneurysm
• History of renal failure
• Life expectancy
• Anaesthetic risk
• Age of patient
• 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 (5.5 mm
O.D.) to 22 French (8.6 mm O.D.) vascular introducer sheath.
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