An Ancure Endograft Stent

Stents are tubes, usually made of metal or plastic, which are placed into vessels or other passages to keep them open. Commonly, stents are used in blood vessels, but have also been used in other areas, such as the esophagus, the uteres to maintain drainage and in coronary arteries. Some stents are used to treat blood vessels injured by trauma.

Endovascular Technologies, a subsidiary of Guidant Corporation, manufactured a device known as the "Stentgraft", which was part of the Ancure Endograft System, and one to two FDA approved endovascular graft devices (EVG). The stent was designed to repair Abdominal Aortic Aneurysms (AAA), which is a bulging of the aorta. The aorta is the largest artery in the body, which originates in the heart and carries blood to the rest of the body. AAAs occurs in the section of the aorta in the abdomen, usually below the kidneys.

The Ancure system utilized a catheter to place a sheath inside the femoral artery of the leg, which was then intended to allow the placement of the stent in the aorta through the leg. It was touted as allowing the repair of AAAs without the need to perform much more dangerous open surgical repair replacing the diseased section with a tubular graft..

On April 27, 2001, the FDA wrote a "Dear Doctor" letter, warning of serious problems that had occurred with the Ancure stent. Guidant reported to the FDA that it had failed to report many device malfunctions, including severe artery damage associated with the deployment of the device.

If you or a loved one has such a stent, it is important that you have regularly scheduled follow-up appointments with your physician, who should prescribe periodic medical imaging such as x-rays and CT scans. Repairs or replacements are sometimes called for.

If you have such a stent, or if you or a family member suffered a serious injury or side effect, or if a loved one died after undergoing an Ancure device operation, please contact Peterson & Associates for further information.

• Summary of Safety and Effectiveness Data
• FDA Public Health Notification: Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm

• Company Caught in Coverup of Medical Device Malfunctions
• Mercury News : Guidant stops making device...
• Mercury News : Heart device firm pleads guilty to hiding problems...