Modified on 2009/10/14 21:50 by admin
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. 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.

See Also

  1. Aneurysm Grafts: Overview
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