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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-11-11-24-670
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems (Transcatheter Aortic Valve Implantation (TAVI))
الأجهزة المتأثرة
Multiple Models & Codes. Please refer to attachment
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
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.
الإجراء التصحيحي
1- For ACURATE neo2, review IFU updates related to valve under expansion, as detailed in the attachment. 2- For ACURATE neo2, complete training on the importance of valve expansion which will be provided by Boston Scientific. 3- For ACURATE Prime, follow existing IFUs and training provided by Boston Scientific. Manufacturer Action: Instructions and Correction.
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