Ancure
The Guidant Ancure Aortoiliac System is blood vessel graft, called an endovascular graft, that is used to repair an abdominal aneurysm. An aneurysm is a diseased or weakened section of an artery wall that tends to balloon or bulge due to arterial blood pressure. The device consists of a woven polyester graft that is housed within a long flexible delivery tube (catheter). The delivery tube containing the graft is inserted through a small incision in the groin where it is advanced through a blood vessel and positioned in the body's largest artery (the aorta) at the location of the aneurysm. The graft is attached to the wall of the aorta with tiny metal hooks. Once it is in place, blood flow can continue through the aorta without filling the aneurysm. This can prevent further growth and possible rupture of the aneurysm.
The Guidant Ancure Aortoiliac System comes in two other configurations, a single tube and a bifurcated (or "Y" shaped tube), which was approved by the FDA in 1999.
In March of 2001, Guidant suspended production of the Ancure and announced a recall of all existing inventory. The company reported to the FDA that they had failed to report many device malfunctions and adverse events, including severe vessel damage associated with problems with the deployment of the device. There were also manufacturing changes that were not properly reported to the FDA. The manufacturer told FDA that an internal audit revealed problems with their complaint handling system, manufacturing quality systems, documentation procedures and training.
If you or a loved one has suffered an injury, illness or death, that seems to have been someone else's fault, call VanDerGinst Law at 1-866-843-7367 or click here for a FREE online case evaluation. The initial consultation is free of charge. If we agree to handle your injury case, we will work on a contingency fee basis, which means we get paid for our services only if, and when, there is a money recovery for you. In many cases a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. So please call right away to ensure that you do not waive your right to possible compensation.
