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This is duplicated text of a letter from Cordis Corporation
Contact the company for a copy of any references, attachments or enclosures. |
IMPORTANT MEDICAL DEVICES SAFETY INFORMATION ON CYPHERTM
CORONARY STENTS AND SUBACUTE THROMBOSIS |
![Company Logo](/web/20061212011858im_/http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/images/cypher_cordis.gif)
July 23, 2003
Dear Health Care Professional:
Subacute Thrombosis in Association with CYPHERTM Coronary Stents
In Canada, it is estimated that 900 CYPHERTM Sirolimus-eluting Coronary Stents have been
implanted since November 2002, when the CYPHERTM Sirolimus-eluting Coronary Stent was granted
a device licence for use in de novo coronary artery lesions with lengths that can be appropriately
covered with a stent 18 mm
and with a reference vessel diameter
2.5 mm and
3.5mm. There
have been no reports of subacute stent thrombosis.
Since the introduction of the CYPHERTM Sirolimus-eluting Coronary Stent in the United States
on April 24, 2003, it is estimated that well over 50,000 patients have received a CYPHERTM Stent.
From the more than 50,000 patient procedures an adverse event report has been received for 47
stents (34 patients) due to stent thrombosis occurring at the time of implantation or within a
few days of implantation. This is less than a 0.1% incidence rate. Some centers have reported
multiple events.
Thrombosis is a rare complication of any coronary stenting procedure. In completed and ongoing
clinical trials of the CYPHERTM Stent worldwide, the rate of stent thrombosis appears to have been
similar to that of a bare metal stent. We are carefully reviewing the adverse event reports received
from U.S. centers to try to determine if the thrombosis rate in current clinical experience differs
from the rate in clinical studies completed pre-approval.
Based on the reports so far, factors impacting the rate of thrombosis may include failure to
achieve adequate stent apposition (due to under-deployment) or suboptimal use of antiplatelet
medication. In addition, Cordis Corporation has become aware that some interventionalists have
been over-expanding smaller stents for use in larger diameter vessels. Overexpansion of stents
beyond their intended diameter may negatively affect performance and is not advisable. Due to the
extremely high demand for the CYPHERTM Stent, Cordis Corporation concentrated its manufacturing efforts
on the 2.5 mm and 3.0 mm diameter CYPHERTM Stents to serve the patient populations with the greatest
perceived potential benefit. We have recently started to introduce the 3.5 mm CYPHERTM Stents.
What You Should Do
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 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
18 mm in native coronary arteries with reference vessel diameters of
2.5 mm 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.
- 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.
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:
Health Products & Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675 |
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