Mri Information - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
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Knowledge of radiographic image interpretation, device selection, and sizing.
A multi-disciplinary team that has combined procedural experience with:
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Femoral cutdown, arterial bypass, arteriotomy, and repair
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Percutaneous access and closure techniques
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Non-selective and selective guidewire and catheter techniques
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Fluoroscopic and angiographic image interpretation
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Embolization
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Angioplasty
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Endovascular stent placement
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Snare techniques
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Appropriate use of radiographic contrast material
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Techniques to minimize radiation exposure
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Expertise in necessary patient follow-up modalities
9.2. Inspection Prior to Use
Inspect the device and packaging to verify that no damage or defects exist. Do not use product after the
"Use By" date on the package. If the device is damaged or the integrity of the sterilization barrier has been
compromised, do not use the product and contact your Medtronic Vascular representative for return
information.
9.3. Materials Required (Not Included in Stent Graft System Packaging)
At the time of surgery have available:
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Additional Endurant Stent Graft Systems (bifurcated, contralateral limb, aortic extension,
abdominal tube, iliac extension, and aortic extension components) of various lengths and
diameters to customize the implant to fit the anatomy of the individual patient.
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Fluoroscope with digital angiography capabilities (C-arm or fixed unit). Fluoroscopic imaging and
the ability to record and recall all imaging.
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Assorted guidewires of adequate length. In addition to guidewires used for accessing the vessel,
0.035"(0.89 mm) diameter guidewires or equivalents must be used to maximally support the
Endurant Delivery System into the aortic vasculature.
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Heparinized saline solution.
9.4. Materials Recommended (Not Included in Stent Graft System
Packaging)
At the time of surgery have available:
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An appropriately sized introducer sheath to provide an adequate conduit for the Endurant
Delivery System to be used.
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Sterile introducer sheaths for introduction into femoral arteries during road mapping or further
diagnostic imaging.
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Power Injector for angiographic contrast studies.
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Assorted balloon catheters to potentially dilate blood vessels prior to insertion of the Endurant
Delivery System.
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Compliant balloon catheters for stent graft expansion following implantation.
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Suitable introducer sheath for compliant balloon.
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Radiopaque contrast media.
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Sterile silicone lubricant or sterile mineral oil.
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Interventional snare devices.
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Curved guidewire.

9.5. MRI Information

Nonclinical testing has demonstrated that the Endurant Stent Graft is MR Conditional. It can be scanned
safely in both 1.5 T and 3.0 T magnetic resonance (MR) systems under the following conditions.
9.5.1. MRI System, 1.5 T
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Static magnetic field of 1.5 T
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Spatial gradient field of 1000 G/cm
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Maximum whole-body-averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of
scanning (or the maximum SAR allowed by the MR System, whichever is less).
In nonclinical testing, the Endurant Stent Graft produced a temperature rise of less than 0.30° C when
normalized to the local specific absorption rate (SAR) for 15 minutes of MR scanning in a 64 MHz whole
body transmit coil, which corresponds to a static field of 1.5 T.
9.5.2. MRI System, 3.0 T
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Static magnetic field of 3.0 T
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Spatial gradient field of 1000 G/cm
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Maximum whole-body-averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of
scanning (or the maximum SAR allowed by the MR System, whichever is less).
In nonclinical testing, the Endurant Stent Graft produced a temperature rise of less than 0.60° C when
normalized to the local specific absorption rate (SAR) for 15 minutes of MR scanning in a 3.0 T MR scanner
(TrioTim, Siemens AG).
9.5.3. Image Artifact (1.5 T and 3.0 T Systems)
Magnetic resonance image quality may be compromised if the area of interest is in the same area or
relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging
parameters for the presence of this implant. The image artifact extends approximately 5 and 8 mm from
the device, both inside and outside the device lumen when scanned in nonclinical testing using the
sequence: spin echo and gradient echo, respectively, in a 3.0 T Siemens TrioTim (VB 13 Software)
MR system with a whole body coil.
Patients with an Endurant Stent Graft Component for the abdominal aortic or aorto-iliac aneurysm may
safely undergo MRI for Normal Mode and First Level Controlled Operating Mode of the MR System, as
defined in IEC Standard 60601-2-33.
9.6. Vascular Access and the Preparation of the Endurant Stent Graft
System
Correct sizing of the aorta and iliac vessels must be determined before implantation of the Endurant Stent
Graft Components using spiral computer aided tomography (CT) as well as angiograms of both the iliacs
and aorta. These images should be available for review during the procedure.
Vascular instruments and other surgical supplies needed to perform surgical cutdowns and to catheterize
access vessels should also be available.
To reduce the risk of thromboembolism, it is recommended that the patient be heparinized for the duration
of the procedure.
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