The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
Contraindications associated with the use of the Express SD Biliary Monorail Premounted Stent System as a transhepatic endoprosthesis include:
- Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis.
- Patients with bleeding disorders.
- Severe ascites.
WARNINGS
- Use only diluted contrast medium for balloon inflation (typically a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium in the balloon.
- Prepare Premounted Stent System per instructions given. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon.
- Do not exceed the maximum rated burst pressure.
- Persons with allergic reactions to stainless steel may suffer an allergic response to the implant.
- Do not expose the Premounted Stent System to organic solvents (i.e. alcohol).
- To reduce the potential for patient injury, the inflated diameter of the balloon should approximate the diameter of the duct just proximal and distal to the stricture. Overstretching of the duct may result in patient injury.
- The Express SD Biliary Stent may cause image artifacts with MRI scans due to distortion of the magnetic field.
- Stenting across a bifurcation could compromise future diagnostic or therapeutic procedures.
PRECAUTIONS
- The device is intended for use by physicians who have received appropriate training.
- The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspect, it should not be used.
- Do not attempt to pull a stent that has not been expanded back through an introducer sheath, since dislodgment of the stent may result. If a stent that has not been expanded needs to be removed, the introducer sheath and the Premounted Stent System should be removed as a unit.
- When treating multiple strictures, the stricture distal to the puncture site should be initially stented, followed by stenting of the proximal stricture. Stenting in this order eliminates the need to cross the proximal stent to achieve placement of the distal stent, and reduces the chance for dislodging the proximal stent with the SDS balloon or Premounted Stent System or dislodging the stent from the SDS balloon.
- The Premounted Stent System is not designed for use with power injection systems. Inflation at a high rate can cause damage to the balloon. Use of a pressure monitoring device is recommended to prevent over pressurization.
- Do not attempt to manually remove or adjust the stent on the SDS balloon.
- The minimally acceptable introducer sheath French size is printed on the package label. Do not attempt to pass the pre-mounted stent system through a smaller size introducer sheath than indicated on the label.
- When catheters are in the body, they should be manipulated only under fluoroscopy. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.
- Never advance the Premounted Stent System without the guidewire extending from the tip.
- 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.
- To ensure expansion of the premounted stent, inflate the Premounted Stent System to at least the opening pressure as shown on the label. To assure nominal sizing of the stent, inflate the Premounted Stent System to nominal pressure as shown on the label.
- Prior to stent expansion, utilize high-resolution fluoroscopy to verify the stent has not been damaged or dislodged during positioning. Expansion of the stent should not be undertaken if the stent is not appropriately positioned in the duct. If the position of the stent is not optimal, it should not be expanded.
- Do not attempt to reposition a partially deployed stent. Attempted repositioning may result in patient injury. Incomplete deployment of the stent (i.e. stent not fully opened) may cause complications resulting in patient injury.
- Recrossing a previously deployed stent with adjunct devices must be performed with extreme caution.
- In the event of complications (such as infections), surgical removal of the stent may be required. Standard surgical procedure is appropriate.
- When multiple stents are required, if placement results in metal to metal contact, stent materials should be of similar composition.
- The Express SD Biliary Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. The Express SD Biliary Stent should not migrate in this MR environment. MR imaging at 3 T or less may be performed immediately following the implantation of the Express SD Biliary Stent.
- In this testing, the stent experienced a maximum temperature rise of 0.96˚C at a maximum whole body averaged SAR of 2.0 W/kg for 15 minutes of MR imaging. The temperature rise was observed to be similar for a stent with a fractured strut. The maximum temperature rise observed for two overlapping Express SD stents was 1.15˚C (5 mm overlap at the ends). MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent.
- This stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 3T.
