FDA warns of blood leak risk with endografts

The FDA warned providers and patients Oct. 28 of risks associated with Endologix's AFX endovascular grafts, which are used to treat abdominal aortic aneurysms. 

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

More articles on supply chain:
J&J recalls baby powder due to asbestos
'Dollars for Docs': 20 drug, device makers that paid physicians the most last year
Facebook's blood donation tool expands to entire US

© Copyright ASC COMMUNICATIONS 2021. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Featured Whitepapers

Featured Webinars