This is filed to report thrombosis.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The transseptal access was achieved; therefore, the steerable guide catheter (sgc) was inserted.While advancing the sgc, it was noticed that thrombus had occurred on the guide wire.It was noted that the activated clotting time (act) remained about 250 throughout the procedure.The sgc was removed and a sheath was inserted over the guide wire.During advancement of the sheath, it was noticed that the thrombus had suddenly become attached to the sheath.Therefore, the physician removed the sheath, and the thrombus was successfully removed with the sheath.The sgc was reinserted and one clip was successfully implanted, reducing mr to a grade of 1+.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 the reported event.Based on the available information, a cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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