Boston Scientific TAXUS / Express2 Drug-eluting Coronary Stents

Modified on 2009/10/14 21:46 by admin
The Taxus stent system consists of a stent (small metal tube) which is mounted on a balloon catheter. The stent is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery. When the stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery restoring normal blood flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The stent remains permanently implanted supporting the newly opened section of the vessel. A drug, paclitaxel, is slowly released into the artery wall around the stent. The drug reduces the chance of vessel narrowing again in the stented segment of the vessel.

In July 2004, the U.S. Food and Drug Administration (FDA) and Boston Scientific Corporation notified healthcare professionals of a Class I recall of two lots of the Taxus drug-eluting coronary stent system (lots 6294706 and 6365192). Characteristics in the design of these two lots resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement. The FDA has received reports of one death and over a dozen serious injuries linked to balloon deflation. Nearly 100 hospitals in the United States use the Taxus stent.

Boston Scientific expanded its recall to include 85,000 Taxus drug-coated stents, up from only 200. The company has also recalled 11,000 Express2 metal heart stents due to a similar problem with the device's delivery system. Boston Scientific has received reports of two deaths and 25 injuries related to the Express2 stent.

Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.

If you have suffered injuries due to the TAXUS 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.

See Also

  1. Heart Devices: Overview
  Name Size