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470 Evergreen Woods,
Bangor, Maine 04401
Phone: 207.942.2898 Fax: 207.941.8818 |
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GUIDANT/STENT-GRAFT INJURIES In 1999, Guidant, a medical supply corporation, received FDA approval to market the Ancure® Endograft system (known as a "stent graft"). The stent graff was used to treat abdominal aortic aneurysms (AAA). The purpose of Guidant's stent graft was to prevent collapsing of aortic walls by reinforcing them with a stent graft made of fabric and fixed inside the blood vessel with metal hooks. Problems with the product occurred when surgeons had problems removing the delivery system for the device. The catheter used to replace the implant would become lodged in the patient and often the surgeon would have to break the handle from the catheter in order to remove it. Deaths have been reported from the malfunction of the Guidant Ancure stent graft. Although these malfunctions were supposed to be reported to the FDA, many adverse events were concealed by Guidant. Federal charges were brought and the company pleaded guilty to charges that they covered up serious malfunctions, including reports of 12 deaths and 57 surgeries to remove the device. The device was removed from the market in October, 2001. Guidant now faces several lawsuits on behalf of patients who have encountered serious problems or died as a result of the device. If you or a family member have been injured by this defective medical device, contact us for assistance and more information. | |