Exemption number (b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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 mixed mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted into the anatomy; however, at this time thrombus was noticed in the right atrium (ra).The sgc was removed and the procedure was discontinued.No clips were implanted, and mr remained at a grade of 3.There was no clinically significant delay in procedure.No additional information was provided.
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