June 15, 2020
Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System
June 15, 2020—Endologix Inc. announced that a correction notice has been issued for the Ovation iX abdominal stent graft system that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed, advised the company.
Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related.
All lots/serial numbers of the following models, not yet implanted, are in the scope of the correction:
- US model numbers: TV-AB2080-J, TV-AB2380-J, TV-AB2680-J, TV-AB2980-J, TV-AB3480-J
- EU model numbers: TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I
- Rest of world model numbers: TV-AB2080-J, TV-AB2380-J, TV-AB2680-J, TV-AB2980-J, TV-AB3480-J, TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I
In addition to new information as to the root cause of leaks, the May 2020 correction notice also contained information regarding the incidence of aneurysm-related complications and the lack of long-term sequelae after underfilling of the polymer rings caused by a polymer leak.
The lifetime present rates of systemic clinical harms are tabulated in the company’s announcement.
These rates are based on voluntary complaint reporting and units sold, which may underestimate the true rate on a per-patient basis and contain less information than would be typical of an analysis from a clinical trial, as such some data are incomplete.
To clarify the decision-making process, Endologix has updated the labeling of the Ovation iX platform with the following warning:
- “Polymer leaks are a unique potential risk of the Ovation iX device platform that have been reported postmarket. The complications of polymer leakage into the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis, and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks and iliac limb complications that have required additional therapy. The risk of polymer leak should be carefully considered, along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Instructions for Use.”
The company announcement includes Endologix and FDA contact information for further questions and reporting of adverse events.
John Onopchenko, Chief Executive Officer of Endologix, stated in the announcement, “Endologix is committed to replacing Ovation iX with the recently FDA-approved Alto graft by the end of October 2020. Alto is technically easier to implant and has been designed to improve acute outcomes, while retaining the unique durability of the Ovation platform. 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 European Union, where the graft is in the final stages of CE Marking review.”
On March 16, Endologix announced FDA approval for the Alto abdominal stent graft system for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms.
Matt Thompson, MD, Chief Medical Officer at Endologix, commented “Ovation iX is differentiated from traditional devices for EVAR through the use of liquid polymer. This technology presents many advantages, including its low-profile graft design with a durable, customized, anatomically adaptive aortic seal. However, it also presents the potential disadvantage of polymer leaks, as addressed in our recent safety communication. In the transition to Alto, physicians may be considering when to select Ovation iX for their patients given the root cause of polymer leaks. Certain patient cohorts, including women, patients with challenging access, patients needing fast-track EVAR, and patients with poor predicted durability using traditional EVAR grafts, may derive incremental clinical benefit from the design features of Ovation iX, as established by existing clinical evidence.”