Ancure® is the registered name for a “stent-graft” device, among several similar devices, used to repair abdominal aortic aneurysms (AAA) without traditional open-chest surgical techniques. The Ancure device – part of the “Ancure Endograft System” – uses a catheter to insert a sheath through the femoral artery in the leg. The Ancure device is made by Endovascular Technologies of Menlo Park, California, a subsidiary of Indianapolis-based Guidant Corporation. On June 12, 2003, Guidant admitted to making false statements to the Food and Drug Administration (FDA) and not submitting required reports of injuries that occurred in patients who received the Ancure device; Guidant agreed to pay $92.4 million in criminal and civil penalties. A complaint filed by federal prosecutors alleged that the Ancure device often malfunctioned, and Guidant sales representatives asked doctors to use it in ways not approved by the government.

Injuries occurring with the Ancure system often arose during implantation. However, other adverse events have included leaks, aneurysms, and ruptures which resulted in extended hospitalizations, additional surgeries, and sometimes death.

The company admitted to failing to report thousands of fatal or life-threatening malfunctions of the device or the highly invasive operations required to correct the damage when the device failed. The criminal complaint alleged that the company reported only 172 malfunctions since the product was introduced in 1999. The complaint also alleged the company had records of 2,628 adverse event incidents, including reports that the malfunctions led to 12 deaths and 57 open heart surgeries.

The law of most states provides several grounds to make a personal injury claim for persons who have been seriously injured by a defective medical device. These grounds include strict liability for a defective product, breach of warranty, negligence and misrepresentation. For persons who have died, their surviving spouse or other family members can bring a wrongful death action. Ashcraft & Gerel is now reviewing Ancure Endograft claims. We have been a leader in mass tort and product liability cases and settlements, including asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen Phen diet drug claims. We have a toll free number to answer your questions with regard to your specific case. That number is 1-800-725-6470. If you would prefer that we contact you, please feel free to email us or complete the help inquiry form on this web site.