Defective Guidant Stents / Ancure

Guidant Ancure Endograft System

The Ancure© Endograft System is a grafting device used to repair abdominal aneurysms introduced by EndoVascular Technologies (EVT), a subsidiary of Guidant Corporation. EVT received approval by the FDA for Ancure© in September 1999 and recalled the product in March 2001, several months after seven anonymous employees reported the failures and problems with the Ancure© system to the FDA. So far, the Ancure© system has been linked to 12 deaths and other serious injuries. EVT was aware of defects with the product's insertion device and failed to disclose all information to the FDA, as required by federal law. The insertion device had the tendency to become lodged inside the patient. Instead of reporting the problem and attempting to rectify the situation, sales representatives formulated a way to deal with the problem on their own. The representatives would instruct physicians to physically break the insertion system into pieces while inside the patient in order to remove the insertion system. Any significant problem with a product is required to be reported to the FDA. EVT knowingly concealed the defects concerning the Ancure© system from physicians, the physicians patients, and regulators.As a result of EVT's deception, they have pled guilty to ten felony counts, including nine for introducing and delivering misbranded products into the market and one for knowingly and willfully making false statements to an FDA official. EVT also agreed to pay $92.4 million in federal penalties for their deceptive actions. If you were treated with an Ancure© system grafting device, we would like to evaluate your possible claim against the manufacturer of Ancure©.

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