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Guidant Ancure News
June 12, 2003
Endovasculat Technologies, INC. Fined $92.4M For Faulty Abdominal Aneurysm Device
On June 12, 2003, EndoVascular Technologies Inc., of Menlo Park, California, a subsidiary of Guidant Corporation, agreed to plead guilty to ten felonies and pay $92.4 million to settle federal civil and criminal charges stemming from its failure to report serious adverse events to the Food and Drug Administration, among other violations.
From September 30, 1999 to March 16, 2001, EndoVascular sold approximately 7,632 ANCURE® ENDOGRAFT® Systems to be used in the treatment of abdominal aortic aneurysms, a potentially life threatening condition. An abdominal aneurysm is a weakened area that develops and forms a balloon in the wall of the aorta, the body's major artery transporting blood from the heart through the abdomen to the rest of the body. If left untreated, the aorta could burst and cause death.
Guidant marketed the ANCURE device as an alternative to the traditional and more invasive treatment for abdominal aortic aneurysms: surgery in which surgeon opens the patient's abdominal cavity, moves aside the internal organs to find the aorta, locate the aneurysm, and attach a graft to the weakened area. Guidant advertised that the "less-invasive ANCURE System procedure provided a variety of benefits to patients, including reduced hospital stay, less blood loss during the procedure, and lower rates of cardiac and respiratory complications."
What happened between September 1999 and March 2001 did not bring benefits to at least 12 patients who died and 57 others whose procedure had to be urgently converted to the traditional open surgical repair which is associated with the risk of arterial trauma, renal insufficiency, and bleeding. These 69 events were among approximately 2,628 incidents that EndoVascular failed to report to the FDA in accordance with the Medical Device Reporting Regulation.
The ANCURE System was composed of two parts:
a.) a vascular endograft -- made of a woven fabric graft with an attachment system using hooks - that remains permanently implanted in the patient's aorta; and
b.) a delivery catheter used to place the endograft into the aorta by insertion through a blood vessel through an incision made in the patient's leg. The surgeon removes the delivery catheter after implanting the endograft.
During ANCURE clinical trials, surgeons found the device more difficult to use than a competing product. After product launch, surgeons found that they were either unable to implant the endograft due to the delivery system or could not succeed in implanting the endograft in keeping with the approved instructions for use. The failure mode - the failure of the sheath of the device to retract as intended - had a complaint rate of approximately twenty percent.
In some cases the delivery system became improperly lodged within the patient, requiring traditional open surgical repair to remove the delivery system and repair the aneurysm. EndoVascular sales representatives, present during the procedures, advised the surgeons to break or cut the system's handle to remove the catheters within the delivery system individually. EndoVascular had not tested the Handle Breaking Technique; the company had not trained the surgeons or the sales representatives on the technique; and FDA had not approved the technique.
If you or a family member may have sustained an injury involving the ANCURE® ENDOGRAFT® System, contact Saunders & Walker at 800-748-7115 or or  . We are representing clients nationwide:
Call us at 1-800-748-7115
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