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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-03-02-25-775
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Pipeline Vantage Embolization Device with Shield Technology
الأجهزة المتأثرة
Product Name (Model Number): Pipeline Vantage Embolization Device with Shield Technology and part numbers PED3-027-XXX-XX (PED3-027-350-XX, PED3-027-400-XX, PED3-027-450-XX, PED3-027-500-XX, PED3-027-550-XX, PED3-027-600-XX) Pipeline Vantage Embolization Device with Shield Technology and part numbers PED3-021-XXX-XX (PED3-021-250-XX, PED3-021-275-XX, PED3-021-300-XX, PED3-021-325-XX, PED3-021-350-XX)
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
The potential of incomplete wall apposition and/or braid deformation noted during the procedure and post-procedure involving the Pipeline Vantage 027 and Pipeline Vantage 021 devices.
الإجراء التصحيحي
Medtronic requires that you immediately take the following actions: 1.Do NOT use any impacted Pipeline Vantage 027 product listed above. Remove and quarantine all unused impacted products listed in Appendix C of the attachment from your inventory. 2.Return the impacted products to Medtronic. 3.Medtronic is implementing changes to the IFU for the Pipeline Vantage 021 with part numbers PED3-021-XXX-XX. The purpose of these changes is to help achieve optimal size selection and stent braid deployment to reduce the risk of complications and patient harms. The key updates are: •Appropriate device diameter and length selection to account for complex anatomy. •Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression to achieve adequate wall apposition and landing around curves. •Warnings about the consequences of incomplete wall apposition and suboptimal deployment and the increased risk of braid deformation in females, especially in females ≤45 years. A copy of the IFU changes is enclosed with the attachment. Manufacturer action: Instructions and Removal.
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