A stent is a medical device — essentially a plastic or metal tube — that doctors permanently place within a blood vessel or artery. This device helps the artery stay open if atherosclerosis has resulted in a buildup of plaque along the arterial wall. Some stents are coated with drugs that allegedly prevent the scarring of the artery as a result of the stent procedure. So far, the Food and Drug Administration (FDA) has approved two primary drug-coated stent devices for manufacture, sale and use in patients.
The two FDA-approved stents are the Cypher Sirolimus-Eluting Coronary Stent, made by a division of Johnson & Johnson, Cordis Corporation (a division of Johnson & Johnson), and the Taxus Express Paclitaxel-Eluting Coronary Stent System, made by Boston Scientific Corporation. There are other drug-coated stents that have been approved by the FDA, but these are the main ones that patients will likely encounter.
Since 2006, the FDA has been concerned about the safety of drug-coated stents, which were first introduced to the medical market in 2003 and 2006. One known risk that has affected some patients — but only in rare cases — is the threat of thrombosis, or blood clotting, after the installation of the stent. Here are some other known risks:
- Blood vessel rupture
- Movement of the stent
- Allergic reaction to the stent device
- Allergic reaction to the drugs in the stent
- Clogging of the stent
- Heart attack and chest pain
If you’ve suffered a complication and injuries from a recently installed, drug-coated stent, you may want to review your legal rights and options as a potential personal injury plaintiff.
Source: FindLaw, “Drug Coated Stents,” accessed Jan. 11, 2018