The National Agency for Food and Drugs Administration and Control (NAFDAC) is alerting health care professionals and patients of the safety concerns associated with the use of Bioprosthetic Aortic Valve with possible risk of reduced leaflet motion.
According to NAFDAC, Bioprosthetic Aortic Valves are aortic valves made of biological tissues mounted on a fabric covered plastic frame called a stent used in management of diseased and dysfunctional native heart aortic valve. Bioprosthetic Aortic Valves are of two types: surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) and this risk is observed in both types.
Last October, the U.S. Food and Drug Administration (FDA) issued similar notifications to healthcare professionals in the U.S.
NAFDAC states that although the use of Bioprosthetic Aortic Valve is reasonably safe when used for its approved indication, it may present with reduced leaflet motion and therefore healthcare professionals are advised to discuss treatment options available to patients. Blood clot deposit on the leaflet may move as emboli to various part of the body leading to reduced blood supply to that part of the body leading to gangrene (death of organ).
There may be potential highly-troubling findings of an increased risk of stroke in patients with Bioprosthetic Aortic Valve found to have reduced leaflet motion
Reporting to NAFDAC
Health care professionals should be aware of this and report adverse events or side effects related to the use of the products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or e-mail: email@example.com .