Potential Adverse Events - Medtronic Valiant Navion Gebrauchsanweisung

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Ensure that the Valiant Navion thoracic stent grafts are placed in an adequate landing zone comprised of healthy tissue.
Healthy tissue is defined as tissue without evidence of circumferential thrombus, intramural hematoma, ulceration, and/or
aneurysmal involvement. Failure to do so may result in inadequate exclusion or vessel damage, including perforation. Refer
to Section 6.1 (Patient selection).
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Any endoleak left untreated during the implantation procedure should be carefully followed after implantation.
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Avoid occluding arterial branches that do not have collateral or protected perfusion to end organs or body structures. If the
LSA is to be covered, check the blood flow of the vertebral or cerebral arteries and the retrograde flow of the LSA.
Caution: Patients with a patent LIMA-LAD (left internal mammary artery-left anterior descending artery) bypass should not
be considered for coverage of the LSA unless additional bypasses are performed prior to the stent graft procedure.
4.4. Magnetic Resonance Imaging (MRI)
MRI may be used on the Valiant Navion thoracic stent graft only under specific conditions. Refer to Section 11.5 (MRI safety
information).
5. Adverse events

5.1. Potential adverse events

Adverse events or complications associated with the use of the Valiant Navion thoracic stent graft system that may occur or
require intervention include, but are not limited to:
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Access failure
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Access site complications (e.g., spasm, trauma, bleeding,
rupture, dissection)
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Adynamic Ileus
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Allergic reaction (to contrast, antiplatelet therapy, stent
graft material)
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Amputation
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Anaphylaxis
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Anastomotic false aneurysm
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Anesthetic complications
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Aneurysm rupture
■ Angina
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Aortic expansion (for example: aneurysm, false lumen)
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Aortic valve damage
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Aortic vessel rupture
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Arrhythmia
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Arterial stenosis
■ Atelectasis
10 Instructions for Use
Figure 3. Covered stent graft placement zones
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Loss of patency
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Lymphocele
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Myocardial infarction
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Neck enlargement
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Neoplasm
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Nerve injury
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Neuropathy
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Occlusion - Venous or Arterial
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Pain/reaction at catheter insertion site
■ Paralysis
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Paraparesis
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Paraplegia
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Paresthesia
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Perfusion of the false lumen
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Peripheral ischemia
■ Peripheral nerve injury