Cordis S.M.A.R.T.® CONTROL®
Iliac Stent System

Essential Prescribing Information

Indications

The Cordis S.M.A.R.T.® CONTROL® Iliac Stent System is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patent profunda or superficial femoral artery.

Contraindications

There are no contraindications known at this time based on the clinical data.

Warnings/Precautions

  • It is not recommended that stents be used in patients with a history of contrast not amenable to pretreatment with steroids and/or antihistamines, or a hypersensitivity to Nitinol (nickel titanium).
  • Safety and effectiveness has not been demonstrated in patients with:
    • Lesions that are either totally or densely calcified.
    • Patients with uncontrollable hypercoaguability and/or other coagulopathy.
    • Patients with confirmed pregnancy.
    • Pediatric patients.
  • Caution should be taken when stenting patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast medium reaction.
  • It is important to use the correct stent size, as recommended in the "Stent Size Selection Table provided in Section VIII – Instructions for Use". The stent may cause a thrombus or distal embolization, or it may migrate from the site of an implant down the arterial lumen.
  • The device should only be used by physicians who are trained in such interventional techniques as percutaneous transluminal angioplasty and placement of intravascular stents.
  • The long-term outcome following repeat dilatation of endothelialized stents is unknown at present.
  • To avoid the possibility of dissimilar metal corrosion, do not implant stents of different metals in tandem where overlap or contact is possible, with an exception of stents made of 316L stainless steel which are compatible with stents made of nickel titanium alloy.
  • Before insertion of the primary dilatation catheter, the appropriate antiplatelet and anticoagulant therapy should be administered. Aspirin may be used as antiplatelet therapy.
  • When catheters are in the body, they should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality imaging is needed.
  • Do not use the delivery system with a power injection system.

Stent Handling

  • Avoid contaminating the stent. As with any type of vascular implant, infection, secondary to contamination of the stent, may lead to thrombosis or pseudoaneurysm.
  • Do not use with Ethiodol* or Lipiodol* contrast media to avoid possible damage to the stent delivery system components.
  • Do not expose the delivery system to organic solvents (e.g. alcohol).
  • Store in a cool, dark, dry place.
  • Do not use if entire temperature exposure indicator is completely black as the unconstrained stent diameter may have been compromised. The black dotted pattern on the gray temperature exposure indicator, found on the pouch, must be clearly visible. The S.M.A.R.T.® CONTROL® Iliac Stent System is intended for single use only. DO NOT re-sterilize and/or reuse the device.
  • Do not use if the pouch is opened or damaged. If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.
  • Use the stent system prior to the “Use By” date specified on the package.

Stent Placement

  • Do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.
  • Once the stent is partially deployed, it cannot be recaptured using the stent delivery system. Do not attempt to recapture the stent once the stent is partially deployed.
  • Avoid stent placement that may obstruct access to a vital side branch.
  • Overstretching of the artery may result in rupture and life threatening bleeding. Do not overstretch the stent.
  • In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
  • When treating multiple lesions, the most distal lesion should be stented first followed by the stenting of proximal lesions. Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents, which have already been placed. Overlap of sequential stents is necessary but the amount of overlap should be kept to a minimum.

Stent/System Removal

  • In the event of complications such as infections, pseudoaneurysm or fistulization, surgical removal of the stent may be required. Standard surgical procedure is appropriate.

Post Implant

  • Re-crossing a stent with adjunct devices must be performed with caution to avoid stent damage or migration.
  • In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents (e.g. aspirin) may be adversely affected.
  • Antiplatelet therapy should be maintained for at least three months post-procedure.

Adverse Events

  • The following ANTICIPATED adverse events have been identified as possible complications of intravascular stent implantation:
    • Allergic / anaphylactoid reaction
    • Aneurysm
    • Angina / coronary ischemia
    • Arterial occlusion / thrombus, puncture site
    • Arterial occlusion / thrombus, remote from puncture site
    • Arterial occlusion / restenosis of the treated vessel
    • Arteriovenous fistula
    • Arrhythmia
    • Death related to procedure
    • Death unrelated to procedure
    • Embolization, arterial
    • Embolization
    • Stent fever
    • Hematoma bleed, remote site
    • Hematoma bleed at needle, device path: nonvascular procedure
    • Hematoma bleed, puncture site: vascular procedure
    • Hypotension / hypertension
    • Intimal injury / dissection
    • Ischemia / infarction of tissue/organ
    • Local infection
    • Malposition (failure to deliver the stent to the intended site)
    • Migration
    • Pulmonary embolism
    • Pseudoaneurysm
    • Renal failure
    • Septicemia / bacterimia
    • Stroke
    • Vasospasm
    • Venous occlusion / thrombosis, remote from puncture site
    • Venous occlusion / thrombosis, puncture site

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.

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