FDA has issued a Public Health Notification for physicians called "Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA)." The Notification describes problems that have occurred with two products: the AneuRx Stent Graft System, manufactured by Medtronic AVE, and the Ancure Endograft System, manufactured by Guidant Endovascular Solutions. The information below will help to answer questions about endovascular grafts, and about the Notification.
One of these products is called a "stent graft." Are these the stents that are used to treat blocked arteries in people with heart disease?
No. Stents of various kinds are used to reinforce blood vessels in many conditions. Some are used to help keep blocked arteries open. Others are used to treat blood vessels injured by trauma, or to strengthen blood vessels used for access during dialysis procedures. The grafts and stent grafts affected by FDA’s Notification are used only to treat abdominal aortic aneurysms (AAA).
- What is an abdominal aortic aneurysm (AAA)?
An aortic aneurysm is a bulging or "ballooning" that forms in a weakened area of the aorta, the large artery that exits from the heart and carries blood to the rest of the body and to the other major arteries. An abdominal aortic aneurysm occurs in the part of the aorta in the abdomen, usually below the kidneys. Abdominal aortic aneurysms can sometimes leak or rupture, resulting in serious bleeding and possibly death.
- How are they treated?
Abdominal aortic aneurysms may be treated by open surgical repair, where the diseased section of the aorta is surgically replaced with a tubular graft. This is a major surgical procedure. Over the past few years, endovascular grafts and stent grafts have been developed as an alternative to open surgical repair. Although using these devices can avoid major surgery, they are not appropriate for all AAA patients.
- How do these endovascular graft devices work?
An endovascular graft (EVG) is a tubular device placed inside a weakened blood vessel in order to reinforce or strengthen it. The EVG is usually positioned in the blood vessel through a long, narrow tube called a catheter. The catheter is inserted through a small puncture wound in the skin, and the EVG is advanced through the catheter until it reaches the weakened portion of the blood vessel where it is permanently implanted.
- Why has the FDA released a Public Health Notification to physicians about these devices?
We wanted to notify vascular surgeons, radiologists, and other physicians who monitor AAA patients about certain problems that have occurred in manufacturing and using these grafts. The notification describes the problems with each of the two devices, and stresses the importance of monitoring patients who have received them.
- Are these the only two endovascular grafts used specifically to treat AAA?
Yes. These are the only two FDA approved devices for this purpose.
- What kind of problems are associated with these devices?
- Ancure System device (Guidant)
Problems associated with placement of the device within the blood vessels have been reported. When this problem occurred, it was found to be associated with damage to the artery wall.
- AneuRx System device (Medtronic AVE)
Problems such as, leaking, slipping out of place, suture breaks, fabric tears, and poor graft placement have been reported.
FDA and the manufacturers are collecting data that will help in understanding how these problems affect the risks and benefits of using these devices.
- Does this mean that everyone with these grafts is going to experience problems?
No. Some patients have had problems, and some have not. But these devices are new, and there is no way to predict who will develop problems in the future. That’s why it’s so important to have regular checkups if you have one of these grafts.
- What is FDA recommending for someone who has one of these devices implanted?
Becoming knowledgeable about your implant and being a responsible patient is the best advice. That means becoming informed about your implant, following your doctor's recommendations, including taking medications, keeping all scheduled appointments, and adhering to any life style changes that may be recommended. This also means promptly reporting any problems to your doctor that might be associated with your implant.
- What medical follow-up should I have if I have one of these grafts?
If you have one of these implanted grafts, it is very important that you have regularly scheduled follow-up appointments with your physician, who will prescribe periodic medical imaging examinations, such as x rays or CT scans. You should continue to have these checkups as long as you have the graft.
- Because of the reported complications associated with this device, will I have to further limit my activities?
Only your doctor can determine this. That is why it is so important to have continuing, follow-up examinations that include medical imaging.
- If I have one of these implants, what can be done for me if I develop one or more of the complications reported?
There are medical procedures that can be done to repair or replace your endovascular graft. For example, your physician might recommend standard open surgery, if you are an appropriate candidate for this procedure. Endovascular grafting is a a new and evolving technology, and new kinds of grafts might emerge in the future that could replace today’s products. For now, the important thing is to keep your physician informed of any signs of trouble that may be associated with your implant and be sure to keep all follow-up appointments.
- With all the follow-up exams I will need, should I be concerned with the amount of radiation I will be exposed to?
Exposure to radiation is a concern. The degree of risk will vary from patient to patient, depending on age, gender, pregnancy status, and exposure history. Discuss this with your doctor. In certain cases, it might be possible to use imaging procedures that do not involve radiation exposure. It’s very important to discuss radiation exposure with your doctor if you are or may be pregnant.
- Are there other sources of information?
Information on general issues such as : AAA, endovascular grafts, vascular stents, vascular grafts, and CT scans may be found on websites of various organizations and NIH.
See: http://www.medicinenet.com (Select "Diseases and Conditions"); also The National Institutes of Health (NIH) website, at http://search2.google.cit.nih.gov/search?site=NIH_Master&client=NIHNEW_frontend&proxystylesheet=NIHNEW_frontend& output=xml_no_dtd&filter=0&getfields=*&q=&btnG.x=12&btnG.y=5.
- What is FDA doing to keep abreast of the problem?
FDA is requiring that manufacturers of these endovascular grafts let us know about all serious complications associated with their use. And we are asking physicians who use these devices to report to us whenever they observe problems with them.