Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Irvine, Calif.-based company said it issued its recall action in July, sending safety notices to healthcare professionals who use the system. The notice included updated information on comparative Type III endoleak rates associated with the device, as well as patient surveillance recommendations and intervention recommendations.
Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture. Last September the federal safety watchdog warned physicians about the risk of endoleaks with stent grafts used to wall off aneurysms in the abdominal aorta.
Endologix said that the safety notice followed earlier communications, issued in late 2016 and early 2017, requesting the return of all AFX Strata stent graft devices, which had not been manufactured since 2018.
“As outlined at our investor day on October 2, 2018, the AFX Strata product was removed from global inventory in the first half of 2017. Our current commercially available versions of the AFX system, the AFX Duraply and AFX2 products, are manufactured using a different ePTFE processing methodology and include additional product improvements. These AFX Duraply and AFX2 products, while part of the July 2018 safety notice providing updated recommendations to HCPs on how to re-intervene on or through these products, were not the subject of the voluntary product removal actions in December 2016/January 2017. Furthermore, AFX Duraply and AFX2 products were not the subject of the June 19, 2018 FDA letter to HCPs. Through our comprehensive system of post-market surveillance, anonymized registry data, and the only randomized trial to compare EVAR systems (the LEOPARD trial), we have a strong and growing evidence base that supports the use of the AFX Duraply and AFX2 systems for patients with AAA. We are proud of, and committed to, advancing our collaborative work with the FDA on behalf of our patients, customers, and the broader clinical community,” CEO John Onopchenko said in a press release.
In June, the FDA warned of an increased risk of serious endoleaks with the discontinued Strata stent graft.
The FDA said at the time that the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Endologix stopped making the AFX with Strata graft material in July 2014 and recalled all of the devices in December 2016, the FDA said.
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