Warning on Bioprosthetic Aortic Valve

Nafdac’s attention has been drawn to the safety concerns associated with the use of Bioprosthetic Aortic Valve with possible risk of reduced leaflet motion. Bioprosthetic Aortic Valves are aortic valves made of biological tissues mounted on a fabric covered plastic frame called a stent used in management of heart disease and dysfunctional native heart aortic valve. The valve in question is always used when the heart valve can’t be repaired. It is done through a surgery during which the natural valve is removed and a new one is sewn to replace the original one.

The following was the reason for their notification:

According to Nafdac, it has been discovered that although the use of Bioprosthetic Aortic Valve is safe when used for its approved indication, it may present with reduced leaflet motion, they are of the opinion that the surgeons discuss other treatment options with the patients.

They identified the following as possible risks of using the valve:

• 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

They further advised healthcare providers to take note of this and report 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 protected]


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