Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, a conclusive cause for the reported thrombus could not be determined.The reported patient effect of thrombosis, as listed in the mitraclip system instructions for use, 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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This is filed to report thrombosis.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.An ntr clip delivery system (cds) was inserted and grasping as performed.However, while grasping, thrombus was observed on the tip of the steerable guide catheter (sgc).It was noted that at this time, the act level was over 400 seconds.The physician decided to deploy the clip.The cds was removed, but during removal, blood was aspirated through the sgc.Mr reduced to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.
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