It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, and thin and friable leaflets.A mitraclip xtw was implanted without issues, reducing the mr to a grade of 1.On (b)(6), 2024, an echocardiogram was performed and revealed that damage to a leaflet occurred, causing the mr to increase to grade 3-4.It was noted that the previously implanted clip was stable on both leaflets an additional mitraclip procedure was performed, and a mitraclip nt was implanted, reducing the mr to a grade of 2.
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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.The investigation determined the reported recurrent mr appears to be a cascading effect of the tissue injury.However, a cause for the reported tissue injury cannot be determined.Tissue injury and mr are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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