It was reported that on january 31, 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 and enlarged atrium.A mitraclip ntw and a mitraclip nt were implanted, reducing the mr to a grade of 1-2.On an unknown date, the patient returned to the hospital with reduced exercise tolerance and dyspnea.An echocardiogram was performed and revealed that the mitraclip nt had detached from the anterior mitral leaflet (aml) and remained attached to the posterior mitral leaflet (pml) (single leaflet device attachment/slda), causing the mr to increase to a grade of 4.On march 19, 2024, an additional mitraclip procedure was performed, and one clip 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported slda appears to be related to patient morphology/pathology.The patient effect of mr appears to be related to the slda.Non specific ekg/ecg changes (reduced exercise tolerance) and dyspnea appear to be cascading effects of the mr.Non specific ekg/ecg changes, dyspnea, 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 circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
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