Zilver 635® Biliary Self-Expanding Stent
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used palliation of malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
• Contraindications include 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 delivery system through the obstructed
area
• Very small intrahepatic ducts
• Biliary duct strictures of benign etiology
• Biliary obstruction preventing cholangiography
• Concurrent perforated bile duct
• Concurrent bile duct stones
• Patients for whom endoscopic procedures are contraindicated
• Patients with coagulopathy
• Any use other than that specifically outlined in the Intended Use section of this
booklet
WARNINGS
• The safety and efficacy of combined side-by-side with overlapping stents has not been established.
• The safety and effectiveness of this device for use in the vascular system has not been established.
• This stent is not intended to be removed and is considered to be a permanent implant. Attempts to remove the stent after placement may cause damage to the surrounding mucosa.
• This device is not intended to be deployed through the wall of a previously placed or existing metal stent. Doing so could make it difficult or impossible to remove the delivery system.
• The stent contains nickel, titanium, and gold, which may cause allergic reaction in individuals with nickel, titanium, or gold sensitivity.
• These metal biliary stents are not intended to be repositioned or removed after deployment in the bile duct. In case of accidental deployment or improper placement (immediately following deployment), leave the stent in place and placement of a second stent should be attempted.
• Upon removal from package, inspect the product to ensure no damage has occurred. If the package is opened or damaged when received, do not use the device. Visually inspect the device with particular attention to kinks, bends or breaks. If an abnormality is detected that would prohibit proper working condition, do not use the device. Notify Cook for return authorization.
• This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.
• Do not advance the delivery system up into the bile duct after stent deployment has been initiated.
• Do not use the product if there is doubt as to whether the product is sterile.
• Sterile if page is unopened or undamaged.
• After stent placement, alternative methods of treatment such as chemotherapy and irradiation may increase risk of: a) stent migration due to tumor shrinkage, b) stent erosion of the tissue, and/or c) mucosal bleeding.
