H10: additional narratives: an aortic dissection is a tear in the inner lining of the aorta.As a result, blood flows through this newly created false channel, which raises a flap that can occlude blood flow in the true lumen.This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention.There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention.Dissections may result in serious injury, death, and/or require medical or surgical intervention.H3: product evaluation: customer report of suture ring migration was unable to be confirmed through visual observations.As received, the suture ring was located approximately 1inch proximal from tip.No visual damages or abnormalities were found.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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H10: additional narratives updated d4, h4, and h6 per new information received based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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