Warnings And Precautions - Medtronic Valiant Navion Gebrauchsanweisung

4. Warnings and precautions

4.1. Warnings and precautions - General
Caution: Do not attempt to use the Valiant Navion thoracic stent graft system before completely reading and understanding the
information contained in the Instructions for Use. Failure to properly follow the instructions, warnings, and precautions may lead
to serious consequences or injury to the patient.
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The Valiant Navion thoracic stent graft system should only be used by physicians and teams trained in vascular
interventional techniques, including training in the use of this device. Refer to Section 6.2.2 (Recommended skills and
training).
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Always have a vascular surgery team available during implantation or re-intervention procedures in the event that
conversion to open surgical repair is necessary.
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The long-term safety and effectiveness of the Valiant Navion thoracic stent graft system has not been established.
4.2. Warnings and precautions - patient selection, treatment, and follow-up
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Do not attempt to use the Valiant Navion thoracic stent graft system in patients unable to undergo the necessary
preoperative and postoperative imaging. Refer to implantation procedures and follow-up imaging recommendations
in Section 9 (Directions for use), Section 10 (Troubleshooting techniques), and Section 11 (Follow-up imaging
recommendations).
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The Valiant Navion thoracic stent graft system is not recommended in patients who cannot tolerate contrast agents
necessary for intra-operative and postoperative follow-up imaging. Refer to Section 11 (Follow-up imaging
recommendations).
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The Valiant Navion thoracic stent graft system is not recommended in patients exceeding weight and/or size limits which
compromise or prevent the necessary imaging requirements.
■ Before the procedure, perform preoperative planning for access and placement. Refer to Section 6.3 (Recommended
device sizing). Key anatomic elements that may affect successful exclusion of the aneurysm include tortuosity, short
landing zones, and significant thrombus and/or calcium at the implantation sites. In the presence of anatomical limitations, a
longer landing zone may be required to obtain adequate sealing and fixation.
■ The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency may have
an increased risk of renal failure postoperatively.
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Inappropriate patient selection may contribute to poor device performance.
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The Valiant Navion thoracic stent graft system has not been evaluated in the following patient situations and/or populations
in which:
The patient is pregnant.
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The patient requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
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The patient has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft
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(pseudo-/false aneurysm).
The patient has a mycotic aneurysm.
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The patient has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic
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aneurysm.
The patient requires emergent aneurysm treatment, for example, trauma or rupture.
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The patient has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending
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thoracic aorta, and/or in the aortic arch.
The patient requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant.
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The patient has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
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Treatment with the Valiant Navion thoracic stent graft would require intentional revascularization of the brachio-cephalic
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artery, the left common carotid artery, or the celiac trunk.
The patient has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after
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the planned implantation of the Valiant Navion thoracic stent graft. This does not include planned procedures that are
needed for the safe and effective placement of the stent graft (that is, carotid/subclavian transposition,
carotid/subclavian bypass procedure).
The patient has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment
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sites that could compromise fixation and seal of the implanted stent graft.
The patient has a connective tissue disease (for example, Marfan's syndrome, aortic medial degeneration).
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The patient has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
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The patient has had an MI within 3 months of the procedure.
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The patient has had a CVA within 3 months of the procedure.
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The patient has a known allergy or intolerance to the device materials.
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8 Instructions for Use English