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The Ancure abdominal heart stent was first approved by the FDA in 1999 for the treatment of a common and often fatal condition called abdominal aortic aneurysm (AAA). This condition causes a weakness in the artery carrying blood from the heart through the abdomen to the rest of the body. The Ancure abdominal heart stent was designed to hold up these arteries to prevent AAA complications. The procedure used to insert this medical device is much less invasive than traditional techniques. For this reason, the Ancure abdominal heart stent has been used in thousand of AAA patients.

The makers of the Ancure abdominal heart stent, Guidant Corporation, recently pled guilty to ten felony counts of making false statements to the FDA about the safety and efficacy of this medical device and fraudulently shipping misbranded medical devices. During the first two years this devise was used, twelve people died, 57 required open heart surgery, and hundreds needed open intra-abdominal surgeries as a result of serious injuries caused by Ancure abdominal heart stent complications.

Over 7,600 patients received Ancure abdominal heart stent implants between September 1999 and March 2001. The FDA now has record of over 2,628 cases of serious Ancure abdominal heart stent malfunctions resulting in serious injury or complications. These reports were made to Guidant years earlier but the company intentionally concealed these findings from the public and the government.

Guidant knew about the many defects and complications that could occur with the Ancure abdominal heart stent. Physicians often reported serious complications with implantation of the Ancure abdominal heart stent. On hundreds of occasions, untrained Guidant salespeople would actually instruct surgeons about how to deal with medical complications during an operation.

The most common complication was the inability to remove the catheter from the patient’s body. Guidant employees even developed what came to be known as the “handle-breaking technique” whereby a surgeon would actually have to break the Ancure instruments apart to remove the catheter from a patient’s body. This was rarely successful and often led to serious injuries, including paralysis and death.

In June 2003, the United States Attorney filed suit against Guidant, on behalf of the FDA for these grossly intentional civil and criminal acts. The company was fined $92.4 million after pleading guilty on more than a dozen civil and criminal counts. Numerous lawsuits have also been filed by the victims of this nightmarish ordeal: the patients who suffered serious injury, illness, and even death as a result of Ancure abdominal heart stent defects and manufacturer misdeeds.

The FDA now has information about 75 cases of death and 991 injuries related to Ancure abdominal heart stent complications. If you or a loved one has suffered serious injury as a result of Ancure abdominal heart stent complications, please contact us to speak with a qualified and experienced attorney who can evaluate your case to determine how best to protect and maximize your legal interests.

"Drug Stents May Raise Blood Clot Risk"

Patients who are receiving stents—drug-coated heart devices—have four to five times an increased risk of developing blood clots, according to a new data analysis.

The analysis conducted by the Cleveland Clinic was of 14 studies involving 6,675 ...

» Read More

"Guidant Corp. pays $92.4 million settlement with the U.S. Dept."

Guidant announced on June 16, 2003 that its device to treat abdominal aortic aneurysms, the Ancure abdominal aortic stent, was going to be discontinued. The company has agreed to pay a $92.4 million fine as part of a settlement...

» Read More

Public Health Notification - Frequently Asked Questions About Problems with Endovascular Grafts for Treatment of Aortic Abdominal Aneurysms (AAA).

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