The Cordis PRECISE Nitinol Stent Transhepatic Biliary System is indicated for palliation of malignant neoplasms in the biliary tree.
Contraindications associated with the use of transhepatic biliary endoprostheses include:
- Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis
- Patients with bleeding disorders
- Severe ascites
- The safety and effectiveness of this device for use in the vascular system have not been established.
- Persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.
- The Cordis PRECISE Nitinol Stent Transhepatic Biliary System is intended for single use only. DO NOT resterilize and/or reuse the device.
- This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use.
- Reuse of this product, including after reprocessing and/ or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/ use information all of which present a potential risk to patient safety.
- The black dotted pattern on the grey temperature exposure indicator, found on the pouch, must be clearly visible. Do not use if entire temperature exposure indicator is completely black as the unconstrained stent diameter may have been compromised.
- Do not use if the pouch is opened or damaged.
- Use the stent system prior to the “Use By” date specified on the package.
- Do not use with Ethiodol™ or Lipiodol™ contrast media.
- Do not expose the delivery system to organic solvents (e.g. alcohol).
- The stent is not designed for repositioning or recapturing.
- Stenting across a major bile duct branch could lead to compromised future diagnostic or therapeutic procedures.
- Any secondary expansion of the biliary stent should be performed with a device indicated for biliary stent placement.
- The device is intended for use by physicians who have received appropriate training.
- The delivery system is not designed for use with power
- injection systems.
- When catheters are in the body, they should be manipulated only under fluoroscopy.
- Radiographic equipment that provides high quality images is needed.
- Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.
- The PRECISE Nitinol Stent Transhepatic Biliary System is shipped with the Tuohy Borst valve in the OPEN position (see “Preparation of the Stent Delivery System”) on the 5.5F stent delivery system only.
- Prior to stent deployment remove all slack from the catheter delivery system (see “Stent Deployment”).
- Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. In the PRECISE stent, they have been reported most often in clinical uses for which the safety and effectiveness have not been established. The causes and clinical implications of stent fractures are not well characterized. Care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.
- Store in a cool, dark, dry place.
Potential complications associated with the use of transhepatic biliary endoprostheses may include, but are not limited to:
- Stent misplacement
- Stent migration
- Stent obstruction secondary to tumor ingrowth
- through the stent
- Tumor overgrowth at the stent ends
- Sludge occlusion
- Bile duct perforation
- Parenchymal hemorrhage
- Liver abscess