Transcatheter aortic heart valves in Europe. A market surveillance study

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ABSTRACT - Malfunctioning heart valves can be replaced by a prosthesis. In recent years, new techniques have been developed with less impact on patients, for example the use of a catheter to insert the prosthesis. The first of these 'transcatheter aortic valve implantation devices' (TAVI) became available in Europe in 2007. Since that time, more than 300,000 TAVIs have been implanted, and new generations of the devices have been developed. 

As part of their market surveillance tasks, the Health and Youth Care Inspectorate (IGJ) commissioned RIVM to assess the technical documentation of five TAVI devices. None of the files contained items that were assessed as 'insufficient', and one file contained only 'good' or 'almost good' items. The other four files contained one to two items assessed as 'moderate'. 

In the file items "clinical evaluation" and "post-market surveillance data" some shortcomings were found with the implication that product safety and the safe use of the devices are insufficiently guaranteed with regard to these issues. Shortcomings in the file do not necessarily mean that the device is of insufficient quality. By maintaining complete and accurate files, manufacturers underpin the safety of their products for patients. Manufacturers are required to investigate carefully any shortcomings in their files, and to resolve these in order to comply with the regulations. Manufacturers have indicated that they are currently working to improve their files in order to comply with the new regulations on medical devices published in 2017. 



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