Tryton Side Branch Stent

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WARNINGS

• Use of the Tryton Side Branch Stent in appropriately sized main vessels and side branches is required for safe and effective performance of the device.
• Do not use the Tryton Stent in small side branches [<2.50 mm in diameter by visual assessment or <2.25 mm in diameter by quantitative coronary angiography (QCA)], as its use may lead to an increased risk of adverse cardiac events such as myocardial infarction and the need for repeat revascularization.
• To confirm appropriately-sized side branch diameters, the diameter of the pre-dilation balloon inflated to nominal pressure may be used as a reference.
• Alternatively, the use of quantitative imaging methods such as on-line quantitative coronary angiography, intravascular ultrasound or optimal coherence tomography should be considered.
• Use of the Tryton Side Branch Stent, as with percutaneous coronary stent implantation procedures in general, is known to be associated with the following risks: Vessel thrombosis.
• Increased length of hospital stay relative to those of coronary balloon angioplasty alone.
• Judicious selection of patients to receive this device rather than balloon angioplasty alone is strongly advised.
• Infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture.
• The stent may cause spasm, distal embolization, thrombus, or could migrate from the site of implantation.
• Excessive dilatation of the artery may cause vessel rupture and life-threatening bleeding.
• Stents may not be fully expanded during deployment, particularly in resistant lesions.
• Stent dislodgement from the balloon surface during deployment and/or dislodgment from the target site post-deployment can occur.
• Major bleeding.