Napoli Bern Ripka, LLP Blog

Ancure

The Guidant Ancure system is a blood vessel graft that is used to repair an abdominal aneurism. An Aneurysm is a diseased or weakened section of the artery wall that tends to balloon or bulge due to arterial blood pressure (defined by the FDA). It is used instead of the more invasive open surgery in patients who have an abdominal aortic aneurysm and whose anatomy is not suited for the use of the single tube or bifurcated endograft device. The Ancure device, as part as the Ancure Endograft System, was suspended in 2001 by its manufacturer Guidant.  Ancure is a synthetic graft device that is used to repair abdominal aortic aneurysms. The device was suspended due to the fact that Guidant admitted to making false statements to the FDA and not submitting required reports of injuries that occurred in patients who received the Ancure device. Injuries occurring with the Ancure device include leaks, aneurysms, and ruptures which resulted in extended hospitalizations, additional surgeries, and sometimes death.

In June 2003, Guidant and its subsidiaries agreed to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their Ancure Endograft System. Also, Guidant 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 complaint suspected that Guidant reported only 172 malfunctions since the product was marketed to the public in 1999. The complaint also alleged that Guidant had 2,628 records of adverse event incidents, including reports that the malfunctions led to 12 deaths and 57 open heart surgeries. In April 2001, the FDA sent a letter to health care professionals who had used Ancure, warning them that “serious problems occurred” with the device. Guidant pleaded guilty to nine counts of introducing a misbranded medical device with the intent to defraud or mislead.