Ancure

Plaintiffs' Personal Injury Law Firm

Ancure

The Ancure Endograft System utilizes a "stent-graft" device to repair abdominal aortic aneurysms, or AAA. It was a non-surgical alternative to the rational invasive surgical procedures used to treat AAA. The Ancure, as other types of endografts, were designed to provide an alternative path for the blood to flow through the aorta. By relieving the pressure on the aorta it lessened the chances of it bursting.

AAA is a result of a tear in the part of the aorta that extends into the abdomen. It is a serious condition as this part of the aorta is responsible for the blood flow to the major organs in the abdomen and lower. If the aorta were to rupture and was not caught in enough time, the blood loss could be significant. It has caused the death of more than 85% of the patients who had AAA.

The Ancure Endograft System is made by Endovascular Technologies in California, a subsidiary of the Guidant Corporation. This product was introduced into the marketplace in 1999 and the FDA approved it with the belief that this was a safe and much needed device. The device was implanted and cut down on hospital time and improved the recovery time of the patients.

In March of 2001, the company suspended production of the Ancure and recalled the balance of its entire Ancure inventory. The reason behind this drastic action was the company's own admission to the FDA that it did not report the malfunctions and reports of severe vessel damage due to the use of the Ancure device. Out of 7,500 devices that were sold, 2,500 did not work properly.

It also did not report several manufacturing problems. In addition, the company performed an internal auditor and found problems with compliance, the quality of its manufacturing systems, documentation procedures and training.

Guidant improved the Ancure making more than 20 changes to the design. It re-released the product but when the problems continued, it permanently removed it from the market in June 2003. While the recall was for the Ancure systems that were being sold at the time it did not encompass the patients who had already had the system implanted. The FDA issued a warning for patients to continue to be monitored by their doctors as long as they had the graft in place.

Endovascular Technologies plead guilty to 10 felony charges for not disclosing information regarding the malfunctions of the Ancure system. They agreed to pay $92.4 million in fines, the largest of its kind to date.

If you, someone in your family or anyone you know have had an Ancure Endograft system implanted and has suffered any of the side effects due to the malfunction of the device, please contact us here at Napoli Bern Ripka Law Firm. You may be eligible for compensation through any number of class action suits against the makers of this device.

If you live in New York you can make an appointment to come to our office which is located in the Empire State building. We also have offices throughout the country. We are committed to helping our clients realize the justice that they deserve.

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