Evolution® Biliary Controlled-Release Stent - Uncovered Animation

Evolution® Biliary Controlled-Release Stent - Uncovered
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used in palliation of malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
Those specific to ERCP and any procedure to be performed in conjunction with stent placement.
Additional contraindications include, but are not limited to: inability to pass the wire guide or stent through the obstructed area • biliary duct strictures of benign etiology • biliary obstruction preventing endoscopic cholangiography • concurrent perforated bile duct • those patients for whom endoscopic procedures are contraindicated • patients with coagulopathy, concurrent bile duct stones, very small intrahepatic ducts and any use other than those specifically outlined under Intended Use.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with ERCP include, but are not limited to: allergic reaction to contrast or medication • aspiration • cardiac arrhythmia or arrest • cholangitis • cholecystitis • cholestasis • hemorrhage • hypotension • infection • pancreatitis • perforation • respiratory depression or arrest • sepsis.
Additional adverse events that can occur in conjunction with biliary stent placement include, but are not limited to: allergic reaction to nickel • bile duct ulceration • death (other than due to normal disease progression) • fever • inflammation • ingrowth due to tumor or excessive hyperplastic tissue • nausea • obstruction of the pancreatic duct • pain/discomfort • perforation • recurrent obstructive jaundice • stent migration • stent misplacement • stent occlusion • trauma to the biliary tract or duodenum • tumor overgrowth • vomiting.
PRECAUTIONS
Refer to the package label for the minimum channel size required for this device.
A complete diagnostic evaluation should be performed prior to placement to measure the stricture length and determine the proper stent length. The stent length chosen should allow for additional length on either side of the stricture.
Note: In the event a single stent will not adequately cover the stricture, a second stent of the same diameter should be placed providing adequate overlapping (minimum 1cm) of the initially placed stent to ensure a bridging of the stricture
between the stents.
If wire guide or stent cannot advance through obstructed area, do not attempt to place stent.
Stent should be placed using fluoroscopic and endoscopic monitoring.
The stent should only be placed with the Cook delivery system, which is provided with each stent.
This stent is intended for palliative treatment only. Alternate methods of therapy should be investigated prior to placement.
Long-term patency with this stent has not been established. Periodic evaluation of the stent is advised. Assessment must be made to determine the necessity of sphincterotomy or balloon dilation prior to stent placement. In the event sphincterotomy or balloon dilation is required, all appropriate cautions, warnings and contraindications must be observed.
Stent cannot be recaptured after the deployment threshold has been passed. The position of the red marker on the top of the handle in relation to point of-no-return position on the handle label indicates when threshold has been passed.
Do not attempt to reload a deployed stent.
Do not use this device for any other purpose than the stated intended use.
Not compatible with THSF wire guide.
Use of this device is restricted to a trained healthcare professional.
Passing a delivery system through a just deployed stent may cause a previously placed stent to dislodge. To reduce the risk of stent dislodgement ensure that the delivery system is completely recaptured following stent deployment.