This is filed to report the suspected thrombus or tissue damage.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were deployed on the mitral valve, reducing mr to a grade of 1.However, prior to removing the steerable guide catheter (sgc), thrombus or a small piece of tissue was observed on the septum.The sgc was removed, and the thrombus or tissue remained on the septum.No additional treatment was performed.There was no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the available information, the cause of the reported thrombus or tissue injury cannot be determined.The reported thrombus or tissue injury as listed in the instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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