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.The reported patient effect of thrombosis, as listed in the mitraclip instructions for use, is a known possible complication associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the thrombosis.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is filed to report thrombus.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The transseptal puncture was performed and heparin was injected.After insertion of the steerable guide catheter (sgc), thrombus was visible near the sgc tip, close to the aorta and fossa ovalis.Additional heparin was administered, and the thrombus resolved.The decision was made to discontinue the procedure.No clips were implanted.Mr remained at 4.There was no adverse patient sequela or a clinically significant delay in procedure.On (b)(6) 2020, two clips were implanted; reducing mr from 4 to 1-2.No additional information was provided.
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