Arterial Stents / Drug Coated Stents
Manufacturer:
Endovascular Technologies
Uses: Strengthens the aorta as it passes through the abdomen
More Information
Stents are tubes, usually made of metal or plastic, which are placed into
vessels or other passages to keep them open. Commonly, stents are used in blood
vessels, but have also been used in other areas, such as the esophagus, the
uterus to maintain drainage, and in coronary arteries. Some stents are used to
treat blood vessels injured by trauma.
Endovascular Technologies, a subsidiary of Guidant Corporation, manufactured
a device known as the "Stentgraft", which was part of the Ancure Endograft
System, an FDA-approved endovascular graft device (EVG). The stent
was designed to repair Abdominal Aortic Aneurysms (AAA), which is a bulging of
the aorta. The aorta is the largest artery in the body, which originates in the
heart and carries blood to the rest of the body. AAAs occur in the section of
the aorta in the abdomen, usually below the kidneys.
The Ancure system utilized a catheter to place a sheath inside the femoral
artery of the leg, which was then intended to allow the placement of the stent
in the aorta through the leg. It was touted as allowing the repair of AAAs
without the need to perform much more dangerous open surgical repair.
On April 27, 2001, the FDA wrote a "Dear Doctor" letter, warning of serious
problems that had occurred with the Ancure stent. Guidant reported to the FDA
that it had failed to report many device malfunctions, including severe artery
damage associated with the deployment of the device.
If you or a loved one has such a stent, it is important that you have
regularly scheduled follow-up appointments with your physician, who should
prescribe periodic medical imaging such as x-rays and CT scans. Repairs or
replacements are sometimes called for.
If you have such a stent, or if you or a family member suffered a serious
injury or side effect, or if a loved one died after undergoing an Ancure device
operation, please contact
Peterson & Associates for further information.
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