Medtronic Valiant Navion Gebrauchsanweisung Seite 11

The patient has a known allergy to anesthetic drugs.
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The patient has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not
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amenable to pretreatment.
The patient has an active or systemic infection at the time of the index procedure.
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The patient is less than 18 years old.
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All patients with endovascular repair must undergo periodic imaging to evaluate the stent graft and vessel. Significant
aneurysm enlargement (>5 mm), the appearance of a new endoleak, migration resulting in an inadequate seal zone, or
continued flow into the false lumen in the case of a dissection, should prompt further investigation and may indicate the
need for additional intervention or surgical conversion. An increase in aneurysm size and/or persistent endoleak may lead
to aneurysm rupture.
4.3. Warnings and precautions - implant procedure
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Do not bend, kink, or otherwise alter the delivery system prior to implantation because it may cause deployment difficulties.
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Do not advance the guidewire or delivery system if resistance is felt. The cause of resistance must be assessed in order to
avoid vessel or delivery catheter damage.
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Stent graft wire fractures are more likely to occur in conditions with an excessively oversized endoprosthesis, flexion,
kinking, or bending during cardiac or respiratory cycles. Wire fractures may have clinical consequences, such as endoleak,
endoprosthesis migration, or adjacent tissue damage.
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Oversize the aortic portion of the stent graft using the sizing guidelines in Section 6.3 (Recommended device sizing)
and Section 6.4 (Device sizing recommendations).
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Strictly adhere to the Valiant Navion thoracic stent graft system sizing configurations and guidelines (Table 2
through Table 8) when selecting the device size. The appropriate device oversizing is incorporated into the sizing
guidelines. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear.
■ Oversizing of the stent graft to the vessel by more than 10% may be unsafe in the presence of dissecting tissue or
intramural hematoma.
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An inadequate seal zone could increase the risk of endoleak or migration of the stent graft. Migration may also be caused
by deployment of the proximal stent into a thrombus filled or severely angled vessel. Refer to Section 6.1 (Patient
selection).
■ Manipulation of wires, balloons, catheters, and endografts in the thoracic aorta may lead to vascular trauma including aortic
dissection and embolization.
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Wrinkling of graft material may promote thrombus formation. Inflate a conformable balloon within the deployed stent graft
lumen to reduce wrinkling of the graft material.
Note: Medtronic recommends the Reliant balloon for use with the Valiant Navion thoracic stent graft. Data is not available
for use of other balloons for remodeling the Valiant Navion thoracic stent graft.
Use the Reliant device according to the instructions for use supplied with the Reliant stent graft balloon catheter. Do not
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attempt to use the Reliant device before completely reading and understanding the information supplied with the Reliant
stent graft balloon catheter.
Do not use the Reliant stent graft balloon catheter in patients with history of thoracic dissection disease. Do not over-
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inflate the Reliant stent graft balloon within or outside of the graft material.
If the Reliant balloon's proximal and distal radiopaque markers are not completely within the covered (graft fabric)
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portion of a vascular prosthesis when expanding the prosthesis, there is an increased risk of vessel injury and/or
rupture, and possible patient death.
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It is not recommended to position the Valiant Navion thoracic stent graft higher in the vessel in the presence of excessive
calcification or thrombus, due to the increased risk of dislodging material during distal repositioning of the Valiant Navion
thoracic stent graft. Refer to Section 9.5 (Positioning the delivery system).
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Do not advance the Valiant Navion thoracic stent graft system when the stent graft is partially deployed and is apposed to
the vessel wall.
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The proximal end of the covered Valiant Navion thoracic stent graft should not be placed beyond the origin of the left
common carotid artery (Zone 0 or Zone 1). See Figure 3.
Instructions for Use English 9