The Guidant Ancure Endograft Device was a device that was designed to treat abdominal aortic aneurysms. The aorta is the major blood vessel supplying blood from the heart to the body. It runs from the heart through the center of a person’s chest into the abdomen. If a person is afflicted with an abdominal aortic aneurysm, it means that there is an enlarged area, or abnormal bulge or ballooning, in the wall of the lower part of the aorta, the part that is located in the abdomen.
Cardiovascular Technologies, a subsidiary of the Guidance Corporation, manufactured the Ancure device.
The enlarged area is the aneurysm. If an aneurysm ruptures or breaks open, a person can experience life-threatening bleeding. If an aneurysm is small and relatively stable, treatment might involve simply watching it. If it is large and growing quickly, emergency surgery may be required. The surgery to repair it would be major.
The manufacturer designed the Ancure device to be inserted into the abdominal aorta through the femoral artery in the leg. In this way, it could be placed in the aorta without major surgery. The Ancure device was approved by the federal Food and Drug Administration (FDA) in 1999.
What Went Wrong with the Ancure?
The FDA has regulations regarding reports that manufacturers must make regarding the medical devices that they sell. Specifically, manufacturers must report certain adverse events involving the devices they sell to the FDA.
Unfortunately, Guidant failed to comply with these regulations and did not file thousands of reports about adverse events that they should have filed. So, they withheld information about the significant negative side effects of the device. They withheld information from the FDA, doctors, and patients.
During the years when the Ancure device was in use in the U.S., Guidant filed 172 medical device reports with the FDA. However, the company should have filed over 2,600 additional reports because of the number of negative events that occurred in connection with the Ancure. Guidant sold about 7,600 Ancure devices during that period.
It was discovered that many of the injuries people suffered from the Ancure were inflicted when the device was inserted into the femoral artery. Other incidents, such as leaks from the device and ruptures, forced patients to undergo invasive surgeries to correct the damage that patients suffered when the device failed to function as promised. Treatment required extended stays in the hospital. Some events resulted in the death of the patient.
There was a criminal investigation of the Ancure device situation, and in 2003, Guidance admitted that it had made false statements to the FDA. Because it had not submitted required medical device reports to the FDA as required by law, the company agreed to pay about $92.4 million as civil and criminal penalties.
The company admitted that it never submitted reports about thousands of malfunctions that resulted in life-threatening situations. Specifically, the company had records of 2,628 incidents. These included reports of 12 deaths and 45 open-heart surgeries.
As a result of its misconduct, the Guidant company pled guilty to criminal charges and voluntarily withdrew its endograft system from the U.S. markets but continued to claim that the product was safe. The Boston Scientific Company later bought Guidant. Guidant suspended production of this device and announced a recall of all existing inventory in 2001.
The Ancure Endograft device was not withdrawn from the worldwide market until 2002. Approximately 18,000 patients worldwide had been implanted with the device by this time.
The Ancure Endograft device is no longer in use in the U.S., but other comparable and hopefully safer similar devices are used to treat abdominal aortic aneurysms.
What Are My Remedies If I Have Been Injured by an EVAR?
Endovascular aortic aneurysm repair (EVAR) is a medical procedure in which an Ancure-type device is used to repair an aortic aneurysm. It is a medical procedure still done in the U.S., although not with the Ancure device. So while it is unlikely that an Ancure device would injure a person at this time, they may well experience injury by a comparable device inserted during a procedure like the one done with the Ancure device.
If a person has been injured in this way, they might have several options depending on the specific facts of their situation. One option would be a medical malpractice suit against the doctor who provided them with the Ancure device. In light of the history of the Ancure device, if a doctor were to provide a patient with an Ancure device, this might be negligence on the doctor’s part.
Or, a doctor might not have been properly trained in performing the procedure in which an Ancure device is inserted through the femoral artery to treat an abdominal aortic aneurysm. If the doctor attempted this procedure without adequate training, this might be evidence of medical negligence.
Another option for recovering damages for injuries caused by treatment with an Ancure device would be a strict product liability lawsuit. A person would sue the manufacturer and distributors of the Ancure device because they placed a defective product on the market, and because of its defects, it injured the person. A person who sues for strict product liability does not have to prove that the manufacturer or distributor was negligent. They only have to prove that their product was defective and caused them injury.
If a doctor inserted an Ancure device in the recent past, then a person who was injured would have to prove in what way exactly the device was defective. For example, the person would have to show that the device leaked, tore, or ruptured and how this defect caused the person to suffer an injury. It may be that the Ancure was designed improperly. It may have been produced using a design unsuitable for its purpose.
It may have been manufactured improperly, again using a defective or unfit material for the purpose for which the device was to be used. Another likely scenario is that the Ancure device was not sold with the necessary warnings about the type of harm it could cause or how it should be used or not be used in some cases.
If a person’s lawsuit for strict product liability is successful, they will be awarded compensatory damages. This award would reimburse the person for their economic losses, e.g., lost income, the cost of medical care, and non-economic, e.g., pain and suffering.
If a person has died because of negligence related to the manufacture or medical use of an Ancure device, then the person’s close family members would file a lawsuit for wrongful death. Again, this suit could be based on medical negligence or strict product liability.
Do I Need the Help of a Lawyer for an EVAR Injury?
If you are using or have used an Ancure device, you may want to talk to your doctor about it. If you believe that you or a family member have suffered injuries as a result of having an Ancare device, or one that is similar to it, you should contact an experienced class action attorney. They can analyze your case and possibly help you recover damages for your injury.
