Consumer Alert: Guidant Ancure® Endograft System Abdominal Aortic Stents
September 2003
For further inquiries about the Guidant Ancure® Endograft System Abdominal Aortic Stents, feel free to contact Bruce Finzen or Daniel O'Fallon at 1.800.553.9910 or Steven Archer at 1.888.588.5544 or to send them an e-mail click on this link: contact us. |
Guidant Corporation recently pled guilty to 10 felony counts of fraudulently shipping misbranded medical devices and to making a false statement to an Food and Drug Administration (FDA) inspector regarding the Ancure® Endograft System marketed by its wholly-owned subsidiary, EndoVascular Technologies. According to the Plea Agreement, out of the more than 7,600 Ancure® Systems implanted between September 30, 1999 and March 16, 2001, there have been at least 2,628 reported malfunctions, resulting in serious complications that were reported to Guidant—but which Guidant intentionally failed to report to the FDA. Guidant has been fined $92.4 million to settle the criminal and civil charges brought against it by the United States Attorney on behalf of the FDA.
In 1999, Guidant obtained FDA approval to market the Ancure® Endograft System, a "stent graft" for treatment of abdominal aortic aneurysms ("AAA's"). An AAA is a common and frequently fatal condition involving a weak area in the wall of the aorta, the artery that brings blood from the heart through the abdomen and to the rest of the body. In an endovascular stent graft procedure, a catheter (a small tube) is inserted in an incision in the patient's leg and the stent graft is threaded through the catheter to be placed within the aorta at the site of the AAA. The stent portion is a hard tube used to prop open the blocked aorta and the graft portion is a woven fabric with an attachment system to allow placement of the stent.
Physicians using the Ancure® System experienced many complications, including the inability to remove the Ancure® System delivery catheter after placement of the stent graft. The Plea Agreement confirms that on hundreds of occasions a Guidant salesperson, without any medical training, would instruct surgeons in the operating room as to how best to deal with these complications of the defective Ancure® System.
According to the Plea Agreement, without advising the FDA, Guidant actually developed what came to be known as the "Handle-Breaking Technique" where surgeons would, literally, break the Ancure® System apart to try to remove the catheter from inside the patient's body. This technique was itself frequently unsuccessful, requiring surgeons to then perform an emergency invasive surgery to open the patient's abdomen to remove the Ancure® System delivery catheter. The FDA has now confirmed that at least 12 deaths, 57 open heart surgeries and hundreds of open intra-abdominal surgeries occurred as a result of this defective product in just the first two years of its use.
Patients that sustained injuries as a result of the failure of the Ancure® System have sought legal assistance. There are many lawsuits involving the Ancure® System already filed in both state and federal courts. Our offices have been and continue to be involved in and committed to the prosecution of these actions on behalf of the victims of these defectively manufactured products. Please feel free to contact our offices for further information concerning the recall of these Ancure® System medical devices.
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