Global Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of America, ,

On 16-Jun-2020, US-FDA released a recall alert for class I medical Device– Ovation iX Abdominal Stent Graft Systems due to the risks of polymer leaks during implantation

Device Use:

  • This device is used in endovascular treatment for patients with an abdominal aortic or aortoiliac aneurysms (AAA).
  • Aortic Aneurysm is a condition which occurs when the aorta (body’s largest blood vessel) becomes stretched and thin, causing the vessel to bulge or expand.
  • Physicians use these stent grafts to repair aneurysms and reduce the risk of rupture.
  • The Ovation iX Abdominal Stent Graft System uses polymer-based technology to seal off blood from flowing into the aneurysm and to help secure the device in place.

Recall Reason:

Endologix, Inc (the manufacturer of this medical device)-recalled the Ovation iX due to risks of liquid polymer leaks during implantation. 

On 06-Aug-2018, Endologix, Inc. issued an important safety update to their physician users of the Ovation Abdominal Stent Graft System Platform to inform about the polymer leaks that 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 (hypersensitivity), unstable blood pressure, transient and prolonged hemodynamic instability, tissue damage (necrosis), organ failure, cardiac arrest, central nervous system (CNS) problems, and death.

Class I MD recall: This device falls under the category of Class I medical device, as per the classification system by US-FDA. This is the most serious type of recall, because use of these devices might cause serious injuries or death.

Recalled Devices:

On 06-May-2020, Endologix initiated the recall for 5403 medical devices which were distributed since 31-Aug-2015. All lots were affected with this recall having the model numbers- TV-AB2080-J; TV-AB2380-J; TV-AB2680-J; TV-AB2980-J; TV-AB3480-J.

Key information from Endologix:

On May 6, 2020, manufacturer advised the respective customers (physicians using this device) with the below listed information which was released through an Urgent Medical Device Correction notice.

  • To be aware that this notification is an update to the 06-Aug-2018 notice.
  • To be aware that 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.

On 15-Jun-2020, Endologix, Inc. provide below additional information by issuing a correction notice:

  • 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 31-Oct-2020.
  • A new warning to be included in labeling for Ovation iX Abdominal Stent Graft System

 For Queries on this Device Recall: Health care professionals and distributors can contact Endologix through following channels for queries or reporting any adverse events or quality complaints of product.

Via Phone: 800.983.2284

Via email: [email protected].

Voluntary MDI (Medical Device Incident) reporting:

Health care professionals and consumers are advised to report the adverse reactions or quality problems experienced with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and voluntarily submit the report Online.
  • Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.
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