The FDA today gave the recall a Class I designation — its most serious level.
Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were five deaths — though Endologix clarified that two of the five deaths took place following complications after a polymer leak.
The Ovation iX system uses polymer-based technology to seal off blood from flowing into an aneurysm and to help secure the device in place. The company in a previous August 2018 safety update warned of leaks taking place due to incorrect device use, but the company now says the problem was material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer.
Endologix isn’t asking health providers to return the 5,403 devices involved in the recall but is instead making doctors aware that they should carefully consider the risk of polymer leaks during implantation against the risks associated with alternative treatment options. The company is updating device labeling accordingly.
FDA earlier this year approved Endologix’s Alto abdominal stent graft system.
“Endologix is committed to replacing Ovation iX with the recently FDA-approved Alto graft by the end of October 2020,” Endologix CEO John Onopchenko said in a news release yesterday.
“Alto is technically easier to implant and has been designed to improve acute outcomes, while retaining the unique durability of the Ovation platform,” Onopchenko said. “Importantly, Alto incorporates design and manufacturing changes that are intended to eliminate the areas of material weakness associated with polymer leaks. We believe Alto should meaningfully reduce the incidence of polymer leaks. We look forward to receiving approval for Alto in the EU, where the graft is in the final stages of CE Marking review.”