Introduction
This article deals with the FDA is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, which include the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets that are externally mounted to the valve frame. The FDA and manufacturer are collaborating to assess the data on Trifecta valves, which have a greater cumulative incidence of early SVD than other commercially available valves. The FDA should contact Trifecta about valve-related events to identify and better understand the risks associated with medical devices and to prompt the reporting of potential safety risks.
The FDA advises healthcare professionals.
- Abbott’s communications on potential risk of early SVD with Trifecta valves and patient care considerations should be taken into account.
- As part of a shared clinical decision-making process before surgery, go over the advantages and disadvantages of all current aortic valve therapy options with your patients and their careers.
- Read and follow IFU when implanting an Abbott Trifecta GT valve.
- Monitor patients for signs and symptoms of potential SVD implantation with Abbott Trifecta valves.
- Request medical attention to help patients with new symptoms such as shortness of breath or fatigue.
- Regular follow-up visits, including TTE assessment, to assess the valve beginning one-year post-implant.
- Inform the FDA of any negative Trifecta valve occurrences. Please see the section below on reporting issues to the FDA.
Background:
Abbott Trifecta Valves are medical devices used to replace natural or artificial aortic heart valves that have become damaged, diseased, or dysfunctional. The FDA has published adverse event reports and published literature to evaluate the security and efficacy of medical devices. According to Abbott’s patient management recommendations degeneration of trifecta valves have a higher incidence of early structural valve degeneration (SVD) and a lesser independence from reintervention due to SVD. To draw conclusions, the FDA received medical device reports (MDRs) indicating effective SVDs in Trifecta valves, which can result in surgical valve explanation/replacement, transcatheter valve-in-valve intervention, and, in some cases, death. Reports filed with the FDA are one source of information used to monitor the safety of medical devices.
FDA Actions:
- The FDA is working with the manufacturer to further evaluate the issue and, if necessary, develop new patient treatment methods.
- The FDA will keep an eye on the research and reports of adverse events connected to the problem.
- The FDA will inform the public if any significant new information or recommendations are made.
FDA Problem Reports:
The FDA urges medical professionals to report any suspected or actual adverse events related to Abbott Trifecta valves.
- With MedWatch, the FDA Safety Information and Adverse Event Reporting programmed, voluntary reports can be made.
- Manufacturers of devices and user facilities are required to abide by all applicable Medical Device Reports (MDR) standards.
- The FDA’s user facility reporting requirements should be adhered to by healthcare employees in facilities that are subject to those regulations.
Conclusion:
The FDA is aware of the potential risk of early structural valve degeneration (SVD) from the Abbott Trifecta valves, which contain leaflets externally affixed to the valve frame. To assess the problem, the FDA is collaborating with the manufacturer to create new patient treatment techniques, and healthcare professionals are encouraged to notify the FDA via MedWatch or MDR to identify and understand the risks associated with medical devices and to prompt the reporting of any adverse occurrences.
To receive the most latest medical news from across the world, subscribe to our private Morulaa website. Get assistance registering medical equipment in India and other Southeast Asian countries by contacting us.
Source Link: FDA-Abbott-Trifecta
