Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
The Sentinol Nitinol Biliary Stent System is indicated for transhepatic palliation of malignant neoplasms in the biliary tree.
Contraindications
Contraindications associated with the use of the Sentinol Nitinol Biliary Stent System as a transhepatic endoprosthesis include:
- Stenting of a perforated biliary duct where leakage from the duct could be exacerbated by the prosthesis.
- Patients with bleeding disorders.
- Severe ascites.
Warnings
- The safety and effectiveness of this device for use in the vascular system have not been established.
- Do not expose the delivery system to organic solvents (e.g., alcohol).
- The stent is not designed for repositioning.
- Once the stent is partially deployed, it cannot be "recaptured" or "resheathed" using the stent delivery system.
- Persons with allergic reactions to nickel may suffer an allergic response to this implant.
- Stenting across a major bile duct branch could lead to compromised future diagnostic or therapeutic procedures.
- The temperature exposure indicator found on the pouch must be clearly visible. Do not use if the temperature exposure indicator is red, indicating that stent expansion may have been compromised.
Precautions
- The Sentinol Nitinol Biliary Stent System is intended for single use only. DO NOT resterilize and/or reuse the device.
- 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.
- Do not kink the stent delivery system.
- Never advance the stent delivery system without control of the guide wire.
- When catheters are in the body, they should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality images is needed.
- When treating multiple strictures, the most distal stricture should be stented first followed by the stenting of proximal strictures. Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents that have already been placed
- When multiple stents are required, if placement results in metal to metal contact, stent materials should be of similar composition, and overlapped at least 5 mm.
- Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the stent. If the target stricture is not fully covered, use additional stents as necessary to adequately treat the stricture.
- The minimally acceptable sheath French size is printed on the package label. Do not attempt to pass the stent delivery system through a smaller size sheath introducer than indicated on the label.
- Recrossing a stent with adjunct devices must be performed with caution.
- Do not use if the product package pouch is opened or damaged.
- Store in a cool, dark, dry place.
- Use prior to the “Use before” date.
Potential Complications
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Potential complications may include, but are not limited to:
- Abscess
- Sepsis/infection
- Stent migration
- Stent misplacement
- Drug reactions, allergic reaction to contrast medium or to the implanted device
- Parenchymal hemorrhage
- Bile duct perforation, tear or dissection
- Hemobilia
- Pancreatitis
- Peritonitis
- Cholangitis
- Liver abscess
- Tissue necrosis
- Stent obstruction secondary to tumor growth
- Death
- Tumor overgrowth at the stent ends
- Recurrent stricture
- Sludge occlusion
