The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Hemolytic anemia results from the premature destruction of red blood cells.It has multiple etiologies including autoimmune diseases, genetic disorders, infection, and drug reactions.There are several mechanisms for hemolytic anemia after mitral valve repair.It may be related to the mitral valve repair prosthesis and/or the annuloplasty ring when there is a ¿jet¿ of blood flow created from a para-ring leak, if there is a regurgitant jet directly pointed at the annuloplasty ring or if there is rapid acceleration of the jet within a narrow zone of para-ring dehiscence.In this case, the patient underwent mitral valve repair and developed subsequent hemolysis in the early postoperative period and required valve replacement.A manufacturing related issue was not identified.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.
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