Ovation iX Abdominal Stent Graft System Instructions for Use (IFU) can be accessed at or provided via hard copy upon request to Endologix Customer Service at 800.983.2284.
Endologix: Urgent Medical Device Correction – May 2020.
Correctvie Notice for Ovation iX Abdominal Stent Graft System
A new warning to be included in labeling for Ovation iX Abdominal Stent Graft SystemĬustomers who have questions about this recall should contact their Endologix representative or Endologix Customer service at 800.983.2284.
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.
Updated lifetime rate of polymer leaks and systemic complications.
issued a Press Release with additional information including: Please also notify Endologix of adverse events or quality problems by emailing Endologix at and/or contacting your Endologix representative.Īdditionally, on June 15, 2020, Endologix, Inc.
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.
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.
Ensure that this information is forwarded to physicians within your organization who need to be aware of the content.
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.
Polymer leaks are a unique potential risk of the Ovation iX Abdominal Stent Graft System.
Be aware no product return is required.
#Ovation model numbers update
Be aware this notification is an update to the Augnotice.
sent an Urgent Medical Device Correction Notice to customers informing them of the cause of the polymer leaks.
Health care providers who use the Ovation iX Abdominal Stent Graft System to treat patients diagnosed with an abdominal aortic aneurysm.
Patients who will have procedures using the Ovation iX Abdominal Stent Graft System to treat abdominal aortic aneurysm.
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. Liquid polymer may leak into the patient’s body. 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. The weakened area may gap or open during use, which can cause liquid polymer to leak outside of the device as it is filled. 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. issued an Important Safety Update to their customers reporting the polymer leaks were due to incorrect use of the device. Previously on August 6, 2018, Endologix, Inc. is recalling the Ovation iX due to risks of liquid polymer leaks during implantation. Ovation iX Abdominal Stent Graft System Reason for RecallĮndologix, Inc.
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