The CYPHER Sirolimus-Eluting Coronary Stent (CYPHER stent) was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. The stent, which allows diseased coronary arteries to remain open after being cleared by balloon angioplasty, is coated with a medication that makes reclogging of an artery more difficult. When approved, cardiologists as well as the stent's manufacturer, Johnson & Johnson, hoped the device would help end repeat angioplasty procedures. Since the product's introduction, it is estimated that over 50,000 patients have received a CYPHER stent.In July 2003, Cordis Corporation (Cordis), a unit of Johnson & Johnson, issued a warning letter to health care professionals informing them of the rare but potential risk of thrombosis (blood clots) associated with the use of the CYPHER stent. At the time the letter was sent, the U.S. Food and Drug Administration (FDA) had received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.
The FDA is carefully reviewing the reports of adverse events and is working closely with the company to determine the exact causes and reduce the incidence of thrombosis. From the reports received so far, it is unclear what effect the CYPHER stent has on thrombosis risk and what factors may contribute to the risk. As part of the approval for this product, the FDA required Cordis to undertake post-approval studies, which will help FDA track adverse events more accurately, as well as help determine whether the thrombosis rate in current clinical experience differs from the rate seen in pre-approval studies.
In October 2003, FDA issued a Public Health Web Notification to inform healthcare professionals of sub-acute thromboses (SAT) and hypersensitivity reactions with use of the Cordis CYPHER Coronary Stent. As of October 20, 2003, FDA has received more than 290 reports (>260 US and >25 outside US) involving sub-acute thrombosis (SAT) associated with the CYPHER stent. More than 60 reports of SATs were associated with patient death and the remaining reports were associated with patient injury requiring medical or surgical intervention. FDA also received more than 50 reports, including some deaths, that Cordis considers possible hypersensitivity reactions. The symptoms reported include: pain, rash, respiratory alterations
, hives, itching, fever, and blood pressure changes
If you have suffered injuries due to the CYPHER stent, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Heart Devices: Overview
- Blood Clots
- Blood Pressure: Overview
- Lung & Airway Disorders