Alerta De Seguridad para INSTRUMENTAL FOR HEART VALVES, Model Measuring Device / Dimensioner - models: 7305UX / 73050OD. Record Record Number 10339190370

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company reports that the above-normal transvalvular gradients (> 25 mmHg) of Mosaic Aortic Bioprosthesis occurred at a rate of 0.33 percent (3.3 reports for every 1,000 aortic implants). A subgroup of these valves was explanted within five years of implantation at a general occurrence rate of 0.1 percent (1 explant for every 1,000 aortic implants). Medtronic has determined that the practice of significant oversizing may lead to cases of transvalvular gradients that are higher than expected. Specifically, considerable oversizing, or implanting a valve significantly larger than the native aortic annulus, may result in alteration of the normal movement of the leaflet since the blood flowing through the native ring may not correspond correctly to the size and / or shape of the flow of the Mosaic Aortic Bioprosthesis. In addition, Medtronic concluded that the current Mosaic Aortic Bioprosthesis sizing table (iEOA) and the Shutters / Dimensioners may in some cases contribute to the selection of a larger Mosaic Aortic Bioprosthesis the ideal. #### (10/03/2014): The field action was finalized by the company on 04/08/2014.