Failure mode and effect analysis of Chitra heart valve prosthesis

Artificial heart valves are devices used for replacing diseased natural valves of the human heart. The failure of such a device to perform to its requirements can lead to serious complications, even threatening the life of the recipient. There are many and varied modes of valve failure that can lead to departure from specifications. These failure mechanisms can be broadly classified into (1) intrinsic factors, like prosthesis design, materials and fabrication processes, and (2) extrinsic factors due to remodelling of the heart and lungs subsequent to valvular disease and valve replacement. This failure mode and effect analysis (FMEA) is an attempt to identify the various possible failure modes of the Chitra heart valve prosthesis.