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Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration
Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to inform health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta valve and Trifecta valve with Glide Technology (GT).
Information from published literature suggests a higher cumulative incidence of early SVD for Trifecta valves compared to other commercially available surgical bioprosthetic valves. In addition, the FDA has received reports describing early SVD.
The Letter to Health Care Providers includes important information about Abbott Trifecta and Trifecta GT valves, including:
- Background on the potential risk of early SVD.
- Recommendations for health care providers.
- Actions the FDA is taking to address the issue.
- Instructions for reporting problems with these devices.
The FDA is committed to communicating with health professionals and the public, when needed, to ensure the health and safety of patients in support of our mission to protect and promote public health.
Questions?
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
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