Contraindications

• Total biliary obstructions and postoperative strictures that cannot be dilated to permit passage of the introducer catheter
• Stenting of a perforated duct where leakage from the duct would be exacerbated by placement of a stent
• Patients with bleeding disorders
• Severe ascites

WARNINGS

• This stent is not intended to be removed . Attempts to remove the stent after placement may cause damage to the surrounding mucosa. This stent is considered to be a permanent implant.
• This device is not intended to be deployed through the wall of a previously placed or existing metal stent. Doing so could result in diffuculty or inability to remove introducer.
• Possible allergicreactions to intinol should be considered.
• The safety and effectiveness of this device for use in vascular system have not been established.

PRECAUTIONS

• Manipulation of the product requires high-resolution fluoroscopic control.
• The stent has not been designed to inhibit tumor ingrowth. Tissue may grow through stents.
• Ensure that the red safety lock is not inadvertently removed until final stent release.
• Deploy the stent over an extra stiff or ultra stiff wire guide.
• Repositioning of the device after deployment is not possible since the introducer catheter cannot be re-advanced over the stent once deployment begins.
• This device is designed for single use only. Attempts to reprocess, re-sterilize, and/or reuse may lead to device failure and/or transmission of disease.
• Do not attempt to remove the stent from the introducer system before use.
• Do not attempt to push the handle away from the hub during deployment.
• Do not rotate any part of the system during deployment.
• Do not expose the delivery system to organic solvents(e.g alocohol).
• Do not use power injection system with the delivery system.
• Do not advance the sheath after the stent has been deployed.