Johnson & Johnson Cypher Stent
The Johnson & Johnson Cypher Stent was approved by the FDA in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the Johnson & Johnson Cypher Stent introduction it is estimated that over 50,000 patients have received a stent. To date, FDA has received 47 Medical Device Reports (MDRs) of Johnson & Johnson Cypher Stent thrombosis occurring at the time of implantation or within a few days of implantation.
Cordis Corporation issued a letter to inform healthcare professionals of a rare but potential risk of thrombosis associated with the use of the Johnson & Johnson Cypher Stent. The letter provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.
Healthcare professionals may reduce the likelihood of adverse events if they follow the following recommendations:
- Selection of the appropriate stent size. The stent size should match the diameter of the vessel as closely as possible.
- Selection of appropriate patients for implantation. The stent is indicated for improving coronary luminal diameter in previously untreated vessels and is not indicated for the treatment of restenosis (reclogging of a previously stented vessel).
- Use of an adequate antiplalelet regimen. Doctors are reminded to give adequate doses of medication that reduce the risk of clot formation.
- Use of the proper technique for stent deployment. The stent should be fully deployed and in contact with the vessel wall. Poor stent deployment is a factor that can increase the thrombosis risk.
If you or a loved one has suffered an injury, illness or death, that seems to have been someone else's fault, call VanDerGinst Law at 1-866-843-7367 or click here for a FREE online case evaluation. The initial consultation is free of charge. If we agree to handle your injury case, we will work on a contingency fee basis, which means we get paid for our services only if, and when, there is a money recovery for you. In many cases a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. So please call right away to ensure that you do not waive your right to possible compensation.
