Guidant Ancure Endograft
On June 12, 2003, EndoVascular Technologies, Inc., a Guidant Corporation subsidiary, pleaded guilty to ten felony counts related to dangerous practices involving their popular $10,000 medical device, the Ancure Endograft. Guidant Corporation was fined $92.4 million by the U.S. government for serious misrepresentations and for covering up serious medical problems and death associated with the Ancure Endograft device. Guidant Corporation has admitted that they failed to file 2,628 reports of incidents where the Ancure System malfunctioned or its use was associated with a death or serious injury. Between September 1999 and March 2001, Guidant filed just 172 Medical Device Reports (MDRs) with the Food and Drug Administration (FDA). During the criminal investigation, Guidant admitted that it failed to file an additional 2,628 MDRs. Guidant therefore intentionally misled the FDA. The FDA depends on Medical Device Reports provided by manufacturers to assess the effectiveness and problems with any given product it approves.
Typically, the product manufacturer will receive reports of problems either through physicians or its own employees and forward these complaints to the FDA. This means that Guidant should have reported the 2,628 MDRs that they received in addition to the select 172 that they did forward to the FDA. The FDA does not test new devices, thereby relying and putting its trust in companies that manufacture products such as these to come forward with reports or complaints concerning the device. The Ancure Endograft’s failure rate of 35% caused 12 deaths and 57 emergency open heart surgeries.
The Ancure Endograft is a synthetic “stent graft” device that is used to repair abdominal aortic aneurysms. The device was inserted into the troubled artery through the femoral artery in the leg and inflated to provide support and reinforcement for the blood flow. Abdominal aortic aneurysms are often caused by arteriosclerosis, a condition that effects the elasticity and thickness of the aortic wall. People with high blood pressure are prone to arteriosclerosis and should therefore be aware of their increased risk of developing an abdominal aortic aneurysm. An aneurysm is a bulge or dilation of an artery due to weakness in the artery wall. The primary danger with an aneurysm is rupture. Usually, this medical problem requires major surgery. Aneurysms most often occur in the aorta, the large artery that distributes blood to all of the body’s vital organs except for the lungs. Although we commonly think of the aorta as being near the heart, it actually extends from the heart into the lower abdomen, providing blood to the organs in the abdomen and below. The primary danger associated with all aneurysms, including the abdominal aortic aneurysm, is the chance that the aneurysm may burst. If an aneurysm bursts, the victim is in grave danger from the subsequent internal bleeding and associated kidney failure. In order to prevent such bursting, surgical procedures are often undertaken in an attempt to repair the aneurysm before it can do any serious harm.
The Ancure Endograft System was hailed as the first minimally invasive procedure and safer than major surgery. When the Ancure Endograft is placed into the aorta it acts like a lining to reinforce the walls and prevent rupture. This procedure required two incisions through the groin area and significantly reduced the time a patient had to spend in the hospital. Unfortunately, the device did not work as promised. Within 19 months of being released to the public, over 2,500 Ancure devices had malfunctioned out of a total 7,500 sold. The product was recalled in March, 2001. Five months later, Guidant re-released the Ancure Endograft after making over 20 modifications to the design.
Even after the modifications were made, the device was still faulty and serious injuries were still occurring. The main problem with this device occurred during the insertion process. The graft is inserted through a catheter. The most common problem was that the catheter became stuck and then surgery had to be done to remove it. Another big problem involved sales representatives. The sales representatives are required to be present by the FDA during the endograft implantations. The representatives taught doctors unapproved techniques for dislodging stuck catheters. The sales representatives told the doctors to break the handle of the Ancure device a piece at a time to dislodge it. This risky procedure was never approved by the FDA and was never even tested by the Guidant Corporation. Also, the doctors performing the operations were not properly trained to employ this technique. When that procedure failed, the patient’s chest would have to be opened in order to correct the complications.
There are at least 18,000 patients who have Ancure Endograft implants. If you or a loved one has been injured by an Ancure Endograft, please contact us.
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