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 Express Biliary SD Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Contraindications
none
Warnings
- The safety and effectiveness of this device for use in the vascular system have not been established.
- Stenting across a bifurcation could compromise future diagnostic or therapeutic procedures.
- 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.
- Prep balloon catheter 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 SDS 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 strictures. Overstretching of the duct may result in patient injury.
- The Express Biliary SD Stent may cause image artifacts with MRI scans due to distortion of the magnetic field.
Potential Adverse Effects
Potential complications associated with biliary stenting may include, but are not limited to:
- Abscess
- Sepsis/infection
- Stent migration
- Stent misplacement
- Hemorrhage/Hematoma
- Bile duct injury, including perforation, rupture and dissection
- Total occlusion/obstruction
- Stent embolization
- Drug reaction, allergic reaction to contrast medium
- Death
- Tumor overgrowth at the stent ends
- Parenchymal hemorrhage
- Hemobilia
- Peritonitis
- Cholangitis
- Stent obstruction secondary to tumor growth through the stent
- Pancreatitis
Cautions
- 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 a sheath, since dislodgment of the stent may result. If a stent that has not been expanded needs to be removed, the 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 from the SDS balloon.
- The SDS 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 sheath French size is printed on the package label. Do not attempt to pass the SDS through a smaller size sheath introducer 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 SDS 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.
- Expansion of the balloon dilatation catheter should be monitored during inflation. Do not exceed the maximum recommended inflation pressures as indicated on the product label. Exceeding this pressure increases the potential for balloon rupture and possible duct damage.
- To assure full expansion, inflate the balloon to at least the 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.
Trademark
Express, Tandem Architecture, Micro, Macro, Monorail and Maverick are trademarks of Boston Scientific Corporation or its affiliates.
