FDA categorized the recall of Endologix’s Ovation iX Abdominal Stent Graft System as a Class I event, the agency flagged in a safety notice Tuesday. The recall affects 5,403 devices distributed in the U.S. since August 2015.
The Class I recall marks an escalation of a polymer leak issue it first reported in 2018. Endologix now thinks the leaks are due to a “material weakness,” not incorrect use of the device as it originally concluded.
Another 65 patients suffered adverse events linked to the fault in the time it took Endologix to change its position on the cause. Endologix has received reports of five deaths.
Endologix differentiated Ovation iX from other endovascular aneurysm repair devices through its use of a liquid polymer. The design decision was intended to create a low-profile graft with a durable aortic seal adapted to the anatomy of each patient. However, the design also exposed patients to the risk of polymer leaks.
In 2018, Endologix issued a safety update about that risk. The Irvine, California-based device maker attributed the 47 cases of polymer leak, including three deaths, to excessive catheter manipulation and other user errors.
Last month, Endologix revised its position in a Urgent Medical Device Correction. Now, Endologix says “a material weakness adjacent to the polymer fill channel” is to blame for the leaks. When the channel comes under pressure, it may become compromised, allowing liquid polymer to leak out and cause low blood pressure.
In updated figures published by the company Monday, Endologix said 112 patients have suffered an adverse event linked to the fault, or a little less than 1% receiving the device. Five patients have died, up from three at the time of the 2018 safety update. Other patients have suffered multi-organ failure, cardiac arrest, tissue necrosis and other adverse events. The failure rate, which Endologix thinks may underestimate the problem, rose from 0.65% to 0.88% over the past two years.
All of the devices will stay on the market. To prevent further adverse events, FDA is asking doctors to factor the risk of polymer leaks into their assessments of the pros and cons of Ovation iX and other approaches. Endologix is advising doctors to view sudden low blood pressure as a possible sign that the polymer is leaking and potentially treat the patient for a severe hypersensitivity response.
Endologix also wants doctors to transition to using its newer Alto graft. The company won FDA approval for Alto in March and then set out to convert 40 mid and high-volume Ovation iX users to the new device. Endologix expects the transition to Alto, which it plans to complete by November, to improve patient outcomes.
Endologix CEO John Onopchenko said on a conference call with investors last month that both the manufacturing and device design for Alto were meant to rectify prior material weakness concerns, which should "meaningfully decrease polymer leak rates compared to Ovation iX."
Onopchenko is looking to Alto to improve Endologix’s financial performance. The company's sales dropped 26% from $193 million in 2016 to $143 million last year. The downward spiral has battered the company’s stock price, which has fallen more than 85% over the past year.