This is being filed to report the thrombus requiring aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After insertion of the steerable guide catheter (sgc) into the left atrium (la), a thrombus was discovered on the guide wire.The wire was pulled back into the dilator and during aspiration both were pulled out of the sgc together.After removing the wire from the dilator, the thrombus could be seen hanging from the wire.The patient was heparinized again and the act was checked more frequently.After this incident there was no thrombus again.The procedure was completed with two clips implanted, reducing mr to 1.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a cause for the reported thrombus cannot be determined; however thrombus is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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