Indications, safety and warnings for Express™ LD Iliac OTW, Express™ LD Iliac, and Biliary Stent System 

Express™ LD Iliac

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.

Express™ LD Biliary

The Express LD Biliary Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Express™ LD Iliac

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.

Express™ LD Biliary

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.

Express™ LD Iliac

• Do not exceed the maximum rated burst pressure. Exceeding this pressure increases the potential for balloon rupture and possible vessel damage.
• As with any type of intravascular implant, infection, secondary to contamination of the stent, may lead to thrombosis, pseudoaneurysm or rupture into a neighboring organ or into the retroperitoneum. The stent may cause thrombus or distal emboli to migrate from the site of the implant down the arterial lumen.
• Care should be taken during stent deployment to avoid stent placement beyond the iliac ostium into the aorta as this may result in thrombus formation.
• Do not exceed the maximum expanded stent diameter.
• To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just distal to the stenosis. Overstretching of the artery may result in rupture and life threatening bleeding.
• 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.
• Persons with allergic reactions to stainless steel or its components (for example nickel) may suffer an allergic response.
• Do not expose the premounted stent system to organic solvents (i.e. alcohol).
• The long-term outcome (beyond twenty four months) for this permanent implant is unknown at present.
• Stent placement should only be performed at hospitals where emergency peripheral artery bypass graft surgery can be readily performed.

Express™ LD Iliac

• 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.
• 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.
• 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.
• Do not attempt to pull a stent where deployment has been initiated back through a sheath or guide catheter, since dislodgment of the stent may result. If a stent that has not been fully deployed needs to be removed, the sheath or guide catheter and the premounted stent system should be removed as a unit.
• 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 and guide catheter French size is printed on the package label. Do not attempt to pass the premounted stent system catheter through a smaller size sheath or guide catheter than indicated on the label.
• When a premounted stent system or SDS balloon is in the body, it 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 lesion is not fully covered, use an additional stent as necessary to adequately treat the lesion.
• It is recommended that when stenting multiple lesions, the distal lesions should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent when placing the distal stent and reduces the chances for disrupting the proximal stent.
• Prior to stent expansion, utilize 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 vessel. If the position of the stent is not optimal, it should not be expanded.
• 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 vessel damage.
• To assure full expansion, inflate the balloon to at least the nominal pressure as shown on the label.
• 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.
• Do not attempt to reposition a partially deployed stent. Attempted repositioning may result in severe vessel damage. 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 to ensure that the adjunct device does not get caught within previously placed stent struts.
• In the event of thrombosis of the expanded stent, thrombolysis should be attempted.
• In the event of complications such as infections, pseudoaneurysm, or fistulization, surgical removal of the stent may be required.
• Use prior to the “Use By” date.
• When multiple stents are required, if placement results in metal to metal contact, stent materials should be of similar composition.
• This device contains nickel, which may cause allergic reaction in individuals with nickel sensitivity.

Express™ LD Iliac

Potential adverse events (in alphabetical order) that may be associated with the use of intravascular stents include, but are not limited to, the following:

• Abscess
• Aneurysm
• Arrhythmias
• AV fistula
• Bleeding/Hemorrhage
• Death
• 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
• Hematoma
• Hypotension or Hypertension
• Myocardial infarction
• Need for urgent intervention or surgery
• ·Pseudoaneurysm formation
• Renal Insufficiency or Renal Failure
• Restenosis of the stented artery
• Sepsis/Infection
• Stent migration
• Stroke, TIA, or other cerebrovascular accident
• Thrombosis/Thrombus
• Tissue ischemia/Necrosis
• Vessel injury, including perforation, trauma, rupture, and dissection
• Vessel occlusion