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 available information, the reported slda was due to patient condition.The reported recurrent mr was a cascading event of the reported slda.The cause of the reported tissue injury was unable to be determined.The reported patient effects of mitral regurgitation and tissue injury, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results 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 on may 16, 2022, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4.A mitraclip ntw was implanted without issues, reducing the mr to a grade of 2.On (b)(6) 2024, an echocardiogram was performed and revealed recurrent mr with a grade of 4, a new tiny flail, and that the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda clip, another mitraclip was implanted, reducing the mr to a grade of 1-2.
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