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Recently scanning the various information websites, we observed on the injuryboard.com website, for June 13, 2003, the following:

Guidant Corp., subsidiary, EndoVascular Technologies, Inc. (EVT), agreed Thursday to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their Ancure Endograft System. As far as we can determine these fines are the largest of their kind to date.

Some background on the Ancure. The Ancure endograft system is a synthetic graft device that is used to repair abdominal aortic aneurysms. It received a PMA approval in September 1999. In March 2001 Guidant, suspended production of the device and announced a recall of all existing inventory. At that time 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 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. After 5 months of modifications, the company reintroduced Ancure with FDA approval, and the device is still used in hospitals today

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.

It just goes to show you that it is very difficult to try to circumvent the FDA regulatory requirements. Though, as a company does through a difficult time with a product, making the right decision to deal straight with FDA is the best way to go.

.S. AGENT SECTION

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