This is being filed to report the pericardial effusion.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Difficulty was met advancing the steerable guide catheter (sgc) across the septum therefore a balloon was inserted to aid in expanding the septum.The procedure was then continued, with two clips implanted, reducing mr to 1.After the procedure a small pericardial effusion was noticed.No treatment was performed as the physician deemed it too small and stable.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 analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information reviewed, a cause for the reported difficult or delayed positioning of the anatomy and pericardial effusion could not be determined.The reported patient effect of pericardial effusion 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 issue with respect to manufacture, design, or labeling.
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