The agency said there may be a higher than expected risk of blood continuing to leak into the aneurysm sac, known as a Type III endoleak, with the use of AFX with Duraply and AFX2 endovascular grafts.
If left undetected and without treatment, a Type III endoleak could lead to expansion and rupture of the abdominal aortic aneurysm, resulting in serious patient injury or death.
The FDA emphasized the importance of yearly, lifelong follow-ups for patients who have any type of Endologix AFX graft. The agency also recommended that patients call their provider to find out what graft they have if they underwent surgery for an abdominal aortic aneurysm and are unsure which type was implanted.
The agency also recommended providers make their patients aware of all the risks of the grafts before surgery.
Read the full news release here.
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