Investigation and potential lawsuit against Boston Scientific Corporation for its Taxus Express Coronary Stent System.
The Taxus Stent System is an expandable, stainless steel tube that is used to treat patients with narrowing coronary arteries. On July 2, 2004, nearly 200 stent systems were recalled by their manufacturer, Boston Scientific Corporation, due to reports of several delivery catheter malfunctions. By theory, a catheter with a deflated balloon inside of it is inserted into the body (via a blood vessel) to the narrowed ("infected") section of the artery. The balloon is then inflated within the infected artery, opening up the area by pushing against the artery wall. The balloon and its catheter are withdrawn from the patient. Then the stent (mounted on another deflated balloon catheter) is advanced through the same vessel and positioned within the expanded artery. The balloon on the second catheter is inflated; causing the stent to expand to the size and shape of the arteries inside walls. The balloon on the second catheter (which has conformed to the wall of the artery) is then deflated and removed from the patient.
Problems have been reported by patients when the balloon failed to deflate properly resulting in coronary artery bypass surgery and even death. To date there have been nearly 20 reports of serious injury and one report of death as a result of coronary stent complications. Certain coronary stents have also been linked to blood clots that have formed during and right after surgery, resulting in stroke and, in some cases death. An estimated 220,000 devices have been implanted in the United States since its approval by the FDA in March of 2004. An additional 200,000 devices have been implanted around the world since its introduction to the global market in 2003.
Name (Stock Symbol)
Boston Scientific Corporation (BSX)
Boston Scientific Corporation designs, manufactures and sells medical devices.
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