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Ancure Side Effects Lawsuits | Side Effects: Heart Operation, Open Chest Procedure, Open Heart Surgery | Recurring Malfunctions, Device Failure

Ancure Side Effects May Result In Open Heart Surgery Lawsuits

Ancure | Lawsuits, Lawyers | Side Effects: Heart Operation, Open Chest Procedure, Open Heart Surgery | Recurring Malfunctions, Device Failure, Failed To Report

Guidant Corp has pleaded guilty to covering up malfunctions of its Ancure Endograft System Graft that may have led to 12 deaths and many other complications. The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device during surgery.

The failure to report the malfunctions prevented the public and physicians from learning about ``recurring malfunctions and other risks.'' The company also was accused of failing to report that other, more invasive surgeries were required after the device failed.

The Company pleaded guilty to 10 felonies and agreed to pay $92.4 million in civil and criminal penalties, to settle the federal charges. According to court documents recently unsealed, federal prosecutors said the device often malfunctioned and the company asked doctors to use it in ways not approved by the government.

In many instances, sales representatives in the operating room asked surgeons, in an effort to remove the lodged device, to break it and remove it a piece at a time. When that failed, the chest would have to be opened.

Ancure is a medical device used to treat abdominal aortic aneurysm without evasive traditional surgical techniques. The medical device, part of the Ancure Endograft System, uses a catheter to insert a sheath through the femoral artery in the leg. The device is designed to allow physicians to operate on the heart without opening the chest. When the device failed open heart surgery was required.

Legal Help For Victims Affected By Ancure

If you or a loved one suffered injuries from an Ancure Endograft System Graft Stent, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


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Guidant Settles Lawsuits

Oct 18, 2003 | Mercury News
The owner of a Menlo Park company that made a medical device linked to dozens of deaths has reached an out-of-court settlement of nine lawsuits that claimed malfunctions of the product.The lawsuits had been filed over the past two years against EndoVascular Technologies, a Menlo Park subsidiary owned by medical-device giant Guidant and were dismissed late last month.Terms of the settlement weren't disclosed. The cases had been filed with U.S. District Judge Jeremy Fogel in San Jose.``I am not...

Guidant Workers' Warnings Met With `Hostility,' Letter Says

Aug 6, 2003 | SanJose Mercury News
Employees at the Menlo Park subsidiary of medical-device giant Guidant encountered backlash from senior staff when the workers tried to alert higher-ups about problems ranging from minor glitches to deaths of some patients implanted with a device, according to a letter released by federal regulators.Written anonymously by seven employees and directed to a Guidant executive in October 2000, the letter was also sent to the Food and Drug Administration. It played a large part in the federal...

Medical Firm's Dangerous Secret

Aug 3, 2003 | San Jose Mercury News
When a Guidant Corp. subsidiary pleaded guilty in June to 10 federal felonies, it acknowledged failing to report thousands of malfunctions of a medical device used to repair bulges in the body's main artery. Twelve of the unreported cases ended in deaths.But the problems with the $10,000 device, called the Ancure Endograft System, were no secret inside the Menlo Park subsidiary, EndoVascular Technologies, that made it.Every time a doctor threaded the tubelike device through an incision in the...

Problems With Aneurism Device Well Known, Newspaper Reports

Aug 2, 2003 | AP
Problems with a medical device that is linked to several deaths were widely known at the company that manufactured it, a newspaper reported Sunday.An investigation by The San Jose Mercury News found that officials at EndoVascular Technologies, a subsidiary of Guidant Corp., knew about numerous problems with implanting the Ancure device and hid the malfunctions from the Food and Drug Administration. The newspaper examined public records and documents and interviewed former employees and others...

Guidant Required To Have Monitor

Jul 3, 2003 | San Jose Mercury News
Federal officials will require medical-device giant Guidant to undergo outside monitoring to make sure its Menlo Park subsidiary reports any more problems with a medical device that was linked to 12 deaths.Under the ``corporate integrity agreement'' signed this week, Guidant's subsidiary, EndoVascular Technologies, must hire an independent organization to assess whether the subsidiary is properly reporting information to the Food and Drug Administration involving its device, which repairs...

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