COOK Medical Evolution Gebrauchsanweisung Seite 7

• placement in actively bleeding tumors
• placement in polypoid lesions
Relative contraindications include, but are not limited to:
• uncooperative patient
• coagulopathy
• tracheal compression
• recent myocardial infarction
• cervical arthritis with fixed cervical spine
• large tumor mass occupying the mediastinum
• nonobstructive tumor
• gastric outlet obstruction
• necrotic esophageal mucosa
• acutely angled stenosis
• placement in an esophago-jejunostomy (following gastrectomy)
WARNINGS
• The safety and effectiveness of leaving this stent in place, or removing the Evolution
Esophageal Stent – Fully Covered from a benign lesion beyond 8 weeks has not been
established.
• Exercise care when removing a stent that has significant overgrowth around the stent ends.
• It is not intended to remove a stent from a malignant lesion once original placement
has been completed and confirmed. Attempts to remove the stent after placement in a
malignant lesion may cause damage to the esophageal mucosa.
• Stenting across the gastroesophageal junction may increase the risk of migration.
• The effectiveness of the delivery system cannot be guaranteed if the stent has been
recaptured more than 5 times.
• Testing of overlapping stents has not been completed and is not recommended.
MR Information
Non-clinical testing has demonstrated that this stent is MR Conditional. It can be scanned
safely under the following conditions:
1.5 Tesla Systems
Static magnetic field of 1.5 Tesla
Spatial gradient field of ≤450 Gauss/cm
Normal operating mode (whole-body-
averaged specific absorption rate (SAR)
< 2 W/kg) ("Normal Operating Mode" is
defined as the mode of operation of the
MR system in which none of the outputs
have a value that cause physiological stress
to the patient) for 15 minutes (i.e., per
pulse sequence).
Non-clinical testing was conducted under the following conditions, and produced a
maximum temperature rise of 4.4 ˚C:
3.0 Tesla Systems
Static magnetic field of 3.0 Tesla
Spatial gradient field of ≤720 Gauss/cm
Normal operating mode (whole-body-
averaged specific absorption rate (SAR)
< 2 W/kg) ("Normal Operating Mode" is
defined as the mode of operation of the
MR system in which none of the outputs
have a value that cause physiological stress
to the patient) for 15 minutes (i.e., per
pulse sequence).
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