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, Boston Scientific Corporation, has issued a medical device safety alert concerning its ACURATE neo2 and ACURATE Prime Aortic Valve Systems [HKMD No.: 220350].
Boston Scientific has become aware of new information related to valve under expansion, that emerged from review of the 1-year clinical trial data from the ACURATE IDE.
Detailed investigation of the 1-year data identified valve under expansion as a potential leading contributing factor of the missed primary endpoint. ACURATE neo2 valve under expansion was associated with an increased rate of primary endpoint events compared to cases where the ACURATE neo2 valve was expanded. However, valve under expansion was not previously identified through clinical experiences with the ACURATE neo2 valve nor through ACURATE neo2 post market surveillance.
Valve under expansion can be seen under fluoroscopy during the index procedure and mitigated with appropriate pre-dilation and post-dilation practices. Therefore, Boston Scientific has updated the ACURATE neo2 Instructions for Use (IFUs) for the risk of valve under expansion and the practices that may reduce this risk, as follows:
As ACURATE neo2 is a product with mandatory physician training, Boston Scientific is also updating the ACURATE neo2 global physician training program for the risk of valve under expansion and the practices that may reduce this risk. This is consistent with ACURATE PRIME training already available and deployed to new ACURATE Prime users.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Nov 2024