Archived – Important Medical Devices Safety Information on CypherTM Coronary Stents and Subacute Thrombosis

Issue

What you should do

• 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 CYPHERTM Stents are based on a 6-cell design; the 3.5 mm diameter CYPHERTM Stent is based on a 7-cell design. Use of a CYPHERTM 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 CYPHERTM 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 CYPHERTM 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 CYPHERTM 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.
• Restenosis
• Acute myocardial infarction
• Saphenous vein graft lesions
• Bifurcation lesions
• 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 CYPHERTM 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 CYPHERTM stent upon 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 CYPHERTM 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 CYPHERTM stent upon deployment.
• 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