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this pageGuidant Stops Making Defective Device for Aneurysm Treatment
WASHINGTON, D.C. — June 27, 2003 — The medical device manufacturer, Guidant, has announced that it will stop making Ancure, a graft placed inside weakened blood vessels to reinforce or strengthen them. The move comes a week after its subsidiary, Endovascular Technologies, pleaded guilty to 10 felonies involving Ancure, including misbranding and false statements. The subsidiary agreed to pay a fine of $92.4 million to the government (San Jose Mercury News, June 17, 2003).
Ancure has been linked to 12 unreported deaths in addition to 16 deaths that Guidant did report to the Federal Drug Administration (FDA). The company also admitted in March 2001 that there were at least 2,623 incidents of Ancure complications and malfunctions that had not been previously reported to the FDA. At present, 14 civil suits have been filed against Guidant on behalf of Ancure patients and shareholders.
Ancure is a device for treating an aortic aneurysm, which is a bulging or ballooning that occurs in a weakened area of the aorta, the large artery that exits from the heart and carries blood to the rest of the body. An abdominal aortic aneurysm occurs in the part of the aorta in the abdomen or stomach, often resulting in bleeding or even death.
The Ancure graft is a tubular device that is positioned within the aorta through a tube called a catheter. It becomes permanently implanted in the blood vessel. Ancure’s purpose is to prevent an abdominal aortic aneurysm without the use of major surgery. However, standard surgery may now be recommended for those who have developed complications with this new technology.
See Frequently Asked Questions About Problems with Endovascular Grafts, FDA, for more background information about the treatment of aortic aneurysms. To learn more about medical devices and your legal rights, see Defective Medical Devices and Products. If you or a family member has been injured by a defective medical device, please feel free to contact the attorneys at Brayton Purcell, either through this web site or at our offices. We have represented hundreds of people who have been injured as a result of defective medical products such as artificial implants, intrauterine devices and coronary surgery equipment.