U.S. Food and Drug Administration06.17.20
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
The Ovation iX Abdominal Stent Graft System is intended to treat patients with an abdominal aortic or aortoiliac aneurysms (AAA), a condition that occurs when the body’s largest blood vessel (the aorta) becomes stretched and thin, causing the vessel to bulge or expand. Doctors use stent grafts to repair aneurysms and reduce the risk of rupture. The Ovation iX Abdomional Stent Graft System uses polymer-based technology to seal off blood from flowing in to the aneurysm and to help secure the device in place.
Endologix Inc. is recalling the Ovation iX due to risks of liquid polymer leaks during implantation. Previously on August 6, 2018, Endologix, Inc. issued an Important Safety Update to their customers reporting the polymer leaks were due to incorrect use of the device. By issuing the recall on May 6, 2020, Endologix is clarifying that the root cause for most polymer leaks is a material weakness caused during the manufacturing process. The weakened area may gap or open during use, which can cause liquid polymer to leak outside of the device as it is filled. If there is not enough liquid polymer in the device to seal the aneurysm, blood may continue to flow into the aneurysm, requiring additional procedures to properly seal off the aneurysm. Liquid polymer may leak into the patient’s body. This may cause serious health consequences, including severe allergic type reactions, unstable blood pressure, tissue damage (necrosis), organ failure, cardiac arrest, central nervous system problems, and death.
Healthcare providers using and patients receiving the Ovation iX Abdominal Stent Graft System to treat abdominal aortic aneurysm may be affected.
On May 6, 2020, Endologix Inc. sent an Urgent Medical Device Correction Notice to customers informing them of the cause of the polymer leaks. The notice advised customers to:
Additionally, on June 15, 2020, Endologix Inc. issued a press release with additional information including:
Recalled Product
- Endologix Ovation iX Abdominal Stent Graft System
- Lot Numbers: All lots
- Model Numbers: TV-AB2080-J; TV-AB2380-J; TV-AB2680-J; TV-AB2980-J; TV-AB3480-J
- Manufacturing Dates: 2015 to Present
- Distribution Dates: August 31, 2015 to Present
- Devices Recalled in the U.S.: 5,403
- Date Initiated by Firm: May 6, 2020
The Ovation iX Abdominal Stent Graft System is intended to treat patients with an abdominal aortic or aortoiliac aneurysms (AAA), a condition that occurs when the body’s largest blood vessel (the aorta) becomes stretched and thin, causing the vessel to bulge or expand. Doctors use stent grafts to repair aneurysms and reduce the risk of rupture. The Ovation iX Abdomional Stent Graft System uses polymer-based technology to seal off blood from flowing in to the aneurysm and to help secure the device in place.
Endologix Inc. is recalling the Ovation iX due to risks of liquid polymer leaks during implantation. Previously on August 6, 2018, Endologix, Inc. issued an Important Safety Update to their customers reporting the polymer leaks were due to incorrect use of the device. By issuing the recall on May 6, 2020, Endologix is clarifying that the root cause for most polymer leaks is a material weakness caused during the manufacturing process. The weakened area may gap or open during use, which can cause liquid polymer to leak outside of the device as it is filled. If there is not enough liquid polymer in the device to seal the aneurysm, blood may continue to flow into the aneurysm, requiring additional procedures to properly seal off the aneurysm. Liquid polymer may leak into the patient’s body. This may cause serious health consequences, including severe allergic type reactions, unstable blood pressure, tissue damage (necrosis), organ failure, cardiac arrest, central nervous system problems, and death.
Healthcare providers using and patients receiving the Ovation iX Abdominal Stent Graft System to treat abdominal aortic aneurysm may be affected.
On May 6, 2020, Endologix Inc. sent an Urgent Medical Device Correction Notice to customers informing them of the cause of the polymer leaks. The notice advised customers to:
- Be aware this notification is an update to the August 6, 2018 notice.
- Be aware no product return is required. Polymer leaks are a unique potential risk of the Ovation iX Abdominal Stent Graft System. (Doctors should carefully consider the risk of polymer leaks along with the risks associated with alternative treatment options when making personalized treatment decisions for patients.)
- Ensure that this information is forwarded to physicians within your organization who need to be aware of the content.
- Complete the provided “Ovation Field Safety Notice (FS-0012) Customer Acknowledgement form” and return either in the provided postage paid envelope or email or fax to the address provided in the form.
- Report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Please also notify Endologix of adverse events or quality problems by emailing Endologix at fieldassurance@endologix.com and/or contacting your Endologix representative.
Additionally, on June 15, 2020, Endologix Inc. issued a press release with additional information including:
- Updated lifetime rate of polymer leaks and systemic complications
- Endologix Inc.’s plans to replace Ovation iX Abdominal Stent Graft System with the recently FDA-approved ALTO Abdominal Stent Graft System by October 31, 2020
- A new warning to be included in labeling for Ovation iX Abdominal Stent Graft System
