Mri Safety And Compatibility; Potential Adverse Events; Device Related Adverse Event Reporting; Patient Selection And Treatment - COOK Medical Zenith Universal Distal Body Mode D'emploi

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 Universal Distal Body 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 Universal Distal Body 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, incomplete sealing, or inadequate fixation of
the Zenith Universal Distal Body graft within the vessel may result in
increased risk of endoleak, migration or inadvertent occlusion of the
visceral vessels. Visceral vessel patency must be maintained to prevent/
reduce the risk of renal failure, mesenteric ischemia, and subsequent
complications.
Incorrect deployment or migration of the endoprosthesis may require
surgical intervention.
Inadequate overlap of the Zenith Universal Distal Body graft with a
Zenith proximal device may result in increased risk of migration of the
stent graft. Incorrect deployment or migration of the endoprosthesis
may require surgical intervention.
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.
Take care during manipulation of catheters, wires and sheaths within an
aneurysm. Signi cant disturbances may dislodge fragments of thrombus
which can cause distal embolisation.
Before deployment of the proximal trigger wires, verify that the position
of the access wire guide extends su ciently into the aortic arch.
Care should be taken not to damage or disturb positioning of the graft
after placement in the event recannulation of the graft is necessary.
Moulding Balloon Use (Optional)
Con rm complete de ation of balloon prior to repositioning.
Do not in ate balloon in any vessel outside of graft, as doing so may
cause damage to the vessel. Use the balloon in accordance with its
labelling.
Use care when in ating the balloon within the graft in the presence of
calci cation, as excessive in ation may cause damage to the vessel.
The Captor Haemostatic Valve should be opened prior to insertion and
withdrawal of a moulding balloon.

4.4 MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Zenith Universal Distal
Body graft is MR Conditional according to ASTM F2503. A patient with
this device may be scanned safely after placement under the following
conditions:
Static magnetic field of 3.0 Tesla or 1.5 Tesla
Maximum spatial magnetic gradient of 720 Gauss/cm or less
Maximum MR system reported, whole-body-averaged specific
absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less
(i.e., per scanning sequence)
Normal operating mode.
Static Magnetic Field
The static magnetic eld for comparison to the above limits is the static
magnetic eld pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Systems:
In non-clinical testing, the Zenith Universal Distal Body graft produced
a maximum temperature rise of 1.8°C during 15 minutes of MR imaging
(i.e., for one scanning sequence) performed in a MR 1.5 Tesla System
(Siemens Magnetom, 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 Systems:
In non-clinical testing, the Zenith Universal Distal Body graft produced
a maximum temperature rise of 1.9°C during 15 minutes of MR imaging
(i.e., for one scanning sequence) performed in a MR 3.0 Tesla System
(General Electric Excite, HDx, Software 14X.M5) at an MR system reported
whole-body-averaged SAR of 2.9 W/kg (associated with a calorimetry
measured whole body averaged value of 2.7 W/kg).
Image Artifact
MR image quality may be compromised if the area of interest is within the
lumen or within approximately 50 mm of the position of Zenith Universal
Distal Body graft as found during non-clinical testing using T1-weighted,
spin echo and gradient echo pulse sequence in a 3.0 Tesla MR system
(Excite, General Electric Healthcare, Milwaukee, WI). Therefore, it may be
necessary to optimize MR imaging parameters for the presence of this
stent.
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 Universal Distal Body graft, the clinical bene t of an
MRI scan should be balanced with the potential risk of the procedure.

5 POTENTIAL ADVERSE EVENTS

Adverse events associated either with the Zenith Universal Distal Body or
the implantation procedures 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
Extremity ischemia or neurologic complications (e.g., brachial plexus
injury, claudication)
Fever and localised inflammation
Genitourinary complications and subsequent attendant problems
(e.g., ischemia, erosion, fistula, incontinence, haematuria, infection)
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)
Occlusion of device or native vessel
Open surgical conversion
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)
Splenic injury (e.g., infarction, ischemia)
Vascular access site complications, including infection, pain,
haematoma, pseudoaneurysm, arteriovenous fistula
Vessel damage
Visceral vessel occlusion
Wound complications and subsequent attendant problems (e.g.,
dehiscence, infection)
Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection,
bleeding, rupture, death).

5.1 Device Related Adverse Event Reporting

Any adverse event (clinical incident) involving the Zenith Universal Distal
Body should be reported to Cook Medical Australia immediately. To
report an incident, call your local Cook Aortic Intervention representative
or contact the Quality Assurance Department on 1 800 777 222 (toll free
within Australia) or +61 7 3841 1188.

6 PATIENT SELECTION AND TREATMENT

(Refer to Section 4, Warnings and Precautions)
The Zenith Universal Distal Body sizes are to be selected as described in
this document and all warnings and precautions outlined in Section 4
are to be taken into consideration.
All lengths and diameters of the devices necessary to complete the
procedure should be available to the physician, especially when pre-
operative case planning measurements (diameters/lengths) are not
certain. This approach allows for greater intraoperative exibility to
achieve optimal procedural outcomes. 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 Universal Distal Body
Ability to tolerate general, regional or local anaesthesia
Ilio-femoral access vessel size and morphology (minimal thrombus,
calcium and/or tortuosity) should be compatible with vascular access
techniques and accessories of the delivery profile of a 7.7 mm OD
(20 Fr) and 8.5 mm OD (22 Fr) vascular introducer sheath
Aneurysm anatomy suitable for endovascular repair as specified in
Section 2 above
The final treatment decision is at the discretion of the physician and
patient.

7 PATIENT COUNSELING INFORMATION

The physician and patient (and/or family members) should review
the risks and bene ts 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 bene ts of an endovascular repair, the
physician should assess the patient's commitment and compliance to
post-operative follow-up as necessary to ensure continuing safe and
e ective 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
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