Express™ LD Iliac and Biliary Stent System
Indications, Safety, and Warnings
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
EXPRESS™ LD ILIAC PREMOUNTED STENT SYSTEM
INTENDED USE/INDICATIONS FOR USE
The Express LD Iliac Premounted Stent System is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.
Generally, contraindications for Percutaneous Transluminal Angioplasty (PTA) are also contraindications for stent placement. Contraindications associated with the use of the Express LD Iliac Premounted Stent System include:
- Patients who exhibit persistent acute intraluminal thrombus at the treatment site, following thrombolytic therapy.
- Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy.
- Persons with known allergies to stainless steel or its components (for example nickel).
- A lesion that is within or adjacent to the proximal or distal segments of an aneurysm.
- Patients who experience the complication of arterial perforation or a fusiform or sacciform aneurysm during the procedure, precluding possible stent implantation.
- Patients with excessive vessel tortuosity.
- Patients with perforated vessels evidenced by extravasation of contrast media.
- Persons with allergic reactions to stainless steel or its components (for example nickel) may suffer an allergic response.
- Stent placement should only be performed at hospitals where emergency peripheral artery bypass graft surgery can be readily performed.
- The device is intended for use by physicians who have been trained in interventional techniques such as percutaneous transluminal angioplasty (PTA) and placement of intravascular stents.
- Caution should be taken with patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast medium reaction.
- Prep premounted stent system per instructions given in Operational Instructions. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon.
- Stenting across a bifurcation or side branch could compromise future diagnostic or therapeutic procedures, or could result in thrombosis of the side branch.
- More than one stent per lesion should only be used when clinically indicated for suboptimal results that compromise vessel integrity and threaten vessel closure, such as edge dissection ≥type B (i.e. bailout). The second implanted stent should also be an Express LD Iliac Stent, or a stent of similar material composition, for component compatibility.
Potential adverse events (in alphabetical order) that may be associated with the use of intravascular stents include, but are not limited to, the following:
- AV fistula
- Drug reaction or allergic reaction (including to antiplatelet agent, contrast medium, stent materials, or other)
- Embolization of device, air, plaque, thrombus, tissue, or other
- Extremity ischemia/amputation
- Hypotension or Hypertension
- Myocardial infarction
- Need for urgent intervention or surgery
- Pseudoaneurysm formation
- Renal Insufficiency or Renal Failure
- Restenosis of the stented artery
- Stent migration
- Stroke, TIA, or other cerebrovascular accident
- Tissue ischemia/Necrosis
- Vessel injury, including perforation, trauma, rupture, and dissection
- Vessel occlusion
EXPRESS™ LD BILIARY MONORAIL™ PREMOUNTED STENT SYSTEM
INDICATIONS FOR USE
The Express LD Biliary Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Contraindications associated with the use of the Express LD Biliary 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.
- 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 inflation 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).
- The safety and effectiveness of this device for use in the vascular system have not been established.
- 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 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 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 sheath French size is printed on the package label. Do not attempt to pass the pre-mounted stent system 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.
- 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.
- 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 partially or fully 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.
Potential complications associated with biliary stenting may include, but are not limited to:
- Allergic reaction (to drug, contrast, device or other)
- Bile duct injury, including perforation, rupture and dissection
- Drug reaction
- Entanglement of delivery system in deployed stent
- Need for urgent intervention or surgery
- Parenchymal Hemorrhage
- Recurrent stricture
- Sludge occlusion
- Stent fracture
- Stent migration
- Stent misplacement
- Tissue/tumor ingrowth causing recurrent stenosis or obstruction