Wednesday, 20 January 2016 08:43

Caution On The Use Of Bioprosthetic Aortic Valves Motion With Possible Risk Of Reduced Leaflet

The attention of the Agency 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 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.

Reason for notification

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 and therefore surgeons and cardiologist are advised to discuss on the treatment options available to the patient.

Possible Risks

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

Healthcare provider’s actions

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: This email address is being protected from spambots. You need JavaScript enabled to view it. .

NAFDAC….Safeguarding the health of the Nation

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