1. Follow the Instructions for Use To help ensure that your experience is similar to that observed in pre-approval clinical trials, we strongly advise you to use the product in accordance with the Indications for Use (IFU) and procedures contained in the package insert. Please take particular note of the following: Select the appropriate stent size We recommend that the stent size match the reference vessel diameter as closely as possible. The 2.5 mm and 3.0 mm diameter CYPHER TM Stents are based on a 6-cell design; the 3.5 mm diameter CYPHER TM Stent is based on a 7-cell design. Use of a CYPHER TM Stent in a vessel larger than the indicated stent diameter could adversely affect the stent's performance. Do not use the smaller stents for vessels larger than indicated in the IFU. Select appropriate patients The CYPHER TM stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of lengths less than or equal to (≤) 18 mm in native coronary arteries with reference vessel diameters of greater than or equal to (≥) 2.5 mm to less than or equal to (≤) 3.5 mm. The CYPHER TM stent is NOT indicated for treatment of the following: Restenosis Acute myocardial infarction Saphenous vein graft lesions Bifurcation lesions The safety and effectiveness of the CYPHER TM stent have not been established for these situations. Off- label use is contraindicated as it may be associated with an increase in the rate of thrombosis. Use an adequate antiplatelet regimen In certain in vitro laboratory settings, sirolimus has been shown to potentiate the effect of some platelet agonists. While the clinical significance of the effect is unknown, it is advisable to be sure the patient is receiving a fully effective antiplatelet regimen, including an adequate pre-medication period or optimal loading dose. Administration of continued antiplatelet therapy for two (2) months post-stenting is considered critical. Use the proper technique for stent deployment Be sure that the stent is fully deployed and in contact with the vessel wall. Poor stent apposition due to under-deployment is a factor that can increase the thrombosis risk for any coronary stent. Predilate the lesion with a PTCA catheter. The CYPHER TM stent is not approved for direct stenting. The longitudinal length of pre-dilatation by the PTCA balloon should be limited to avoid creating a region of vessel injury that is outside the boundaries of the CYPHER TM stent upon deployment. 2. Report Your Experience In most product development programs, rare side effects are difficult to detect, and their risks for special populations are difficult to assess. Therefore, as a matter of course, it is important for you to report any product complaints and adverse events directly to Cordis Canada, a Business unit of Johnson & Johnson Medical Products, division of Johnson & Johnson Inc by: Telephone to Customer Service 1 800 268 5577 Mail to the attention of Product Quality Services, Johnson & Johnson Medical Products, 200 Whitehall Dr., Markham ON, L3R 0T5 Please feel free to contact Cordis Canada for any questions you may have on the subject matter of this letter. We, in cooperation with Health Canada, will continue to keep you updated with the latest information. Sincerely, original signed by Dennis Donohoe, M.D. Vice President, Therapeutics and Clinical Research Cordis Corporation Any suspected adverse incident can also be reported to: &Food; Branch Inspectorate HEALTH CANADA Address Locator: 3002C OTTAWA, Ontario, K1A 0K9 Tel: The Medical Devices Hotline 1-800-267-9675 Date modified: 2003-07-30
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