Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The FDA has posted a Letter to Health Care Providers concerning Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT) [HKMD No.:120045]
According to the FDA, published literature suggested a higher cumulative incidence of early (five years or less) structural valve deterioration (SVD) for Trifecta valves compared to other available surgical bioprosthetic valves. Outcomes from these studies suggest a higher cumulative incidence of early SVD and lower freedom from reintervention due to SVD associated with Trifecta valves.
For further information, please visit https://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Feb 2023