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.Based on available information, the cause of the reported pericardial effusion was unable to 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.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4 and flail.A mitraclip ntw was implanted.Another mitraclip ntw was inserted, but a pericardial effusion was observed.The second clip was implanted, reducing the mr to a grade of 1.It was noted that in the physician's opinion, the pericardial effusion occurred while implanting the first clip, but was not observed until implanting the second clip.To treat the pericardial effusion, pericardiocentesis was performed.There was no clinically significant delay in the procedure.
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