Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, St. Jude Medical (Abbott), has issued a medical device safety alert concerning its Navitor Transcatheter Aortic Heart valves [Models: NVTR-27, NVTR-29, NVRO-27, NVRO-29, NVRO-35] [HKMD No.: 220187].
The manufacturer identified an error in the manufacturing step used to measure leaflet deflection. This measurement error led to the acceptance of a limited number of valves with a leaflet deflection value that was outside of its established specifications. Deflection is a mechanical property of bioprosthetic leaflets which characterizes leaflet stiffness. The effect of this was utilizing leaflets that were less stiff. The use of lower-than-expected stiffness of such leaflets could potentially affect long-term durability of the Impacted Valve. Decreased stiffness of the leaflets is theorized to cause potential valve failure due to increased interactions between the valve leaflets and the stent frame and/or inner skirt.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Oct 2024