The Cordis S.M.A.R.T. CONTROL® Nitinol Stent Transhepatic Biliary System is indicated for palliation of malignant neoplasms in the biliary tree.
Contraindications associated with the use of this device include:
- Bleeding disorders
- Inability to tolerate antithrombotic or antiplatelet therapies
- Intra-cranial arteries
- Known hypersensitivity to nickel titanium
- Perforated biliary duct where leakage from the duct could be exacerbated by the stent
- Presence of severe ascites
- Stent of a duct with total biliary occlusion which cannot be crossed by the delivery catheter
This product should only be used by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for interventional procedures should be employed.
- Do not use power injection systems with the delivery system.
- Use in patients with a history of contrast sensitivity is not recommended unless the patient can be adequately pre-medicated.
- Use of this device requires fluoroscopic control.
- The effect of heating in the MRI environment for overlapping stents or stents with fractured struts is not known.
- Safety and effectiveness has not been demonstrated in Pediatric patients
- Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. In the S.M.A.R.T.® stent, they have been reported most often in clinical uses for which the safety and effectiveness have not been established. The causes and clinical implications of stent fractures are not well characterized. Care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.
Potential Complications/Adverse Events
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:
- Abrupt stent closure
- Access failure
- Allergic/anaphylactoid reaction
- Bile duct perforation
- Disseminated intravascular coagulation
- Embolization (air, plaque, thrombus, device or other)
- Gastrointestinal bleed from anticoagulation/antiplatelet medication
- Infection and/or sepsis
- Intimal injury/dissection/rupture/perforation
- Liver abscess
- Parenchymal hemorrhage
- Renal insufficiency or failure
- Sludge occlusion
- Stent malapposition
- Stent migration
- Stent obstruction secondary to tumor ingrowth through the stent
- Stent structure fracture
- Tumor overgrowth at the stent ends