There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology, the FDA says in a letter to HCWs posted on its website.
There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology , the US Food and Drug Administration says in aEvidence in the literature suggests a higher cumulative incidence of early structural valve deterioration and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.
Medical device reports received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant."Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death," the FDA notes.
Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue. The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.
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