Ancure

Napoli Bern Ripka Law Firm

Plaintiffs' Personal Injury Law Firm

Ancure

Ancure is a synthetic graft device that is used to repair abdominal aortic aneurysms. In March 2001 Guidant, the company that manufactures Ancure, suspended production of the device and announced a recall of all existing Ancure inventory. Contact Napoli Bern if you have had this procedure.

The company informed the FDA that it had failed to report many device malfunctions and adverse events, including severe vessel damage, associated with problems in the deployment of the Ancure device. There were also manufacturing changes that were not properly reported to the FDA. The manufacturer told the FDA that an internal audit revealed problems with its complaint handling system, manufacturing quality systems, documentation procedures and training.

In June 2003, EndoVascular Technologies, Inc. (EVT) a subsidiary of Guidant Corp., agreed to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their Ancure Endograft System. The fines are the largest of their kind to date.

As part of the plea agreement, the company admitted that it failed to inform the FDA of more than 2,600 system malfunctions and adverse events (a failure rate of more than 35%), including 12 deaths and 57 emergency surgeries to take out the apparatus.

See your doctor if you have received an Ancure device to repair abdominal complications, aortic aneurysms and you are concerned about your safety. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

ABOUT ANEURYSMS

An aneurysm is a bulge in the wall of an artery. Aneurysms most often occur in the aorta, the large artery that distributes blood to all of the body's vital organs except for the lungs. One of the most common locations along the aorta for an aneurysm to develop is within the abdomen. So-called abdominal aortic aneurysms are often caused by arteriosclerosis, a condition that effects the elasticity and thickness of the aortic wall. People with high blood pressure are prone to arteriosclerosis and should therefore be aware of their increased risk of developing an abdominal aortic aneurysm.

The primary danger associated with all aneurysms, including the abdominal aortic, is the chance that the aneurysm may burst. If an aneurysm bursts, the victim is in grave danger from the subsequent internal bleeding and associated kidney failure. In order to prevent such bursting, surgical procedures are often undertaken in an attempt to repair the aneurysm before it can do any serious harm. Such surgical procedures, including the use of synthetic grafts to repair the aneurysm, can be risky.

Recently, the FDA reported that two brands of synthetic grafts used to repair abdominal aortic aneurysms have been associated with various adverse events. The particular grafts involved are the Ancure, manufactured by Guidant, and the AneuRx, manufactured by Medtronic.

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