On (b)(6) 2024, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4, severe prolapsed leaflet and bileaflet flail.A mitraclip was implanted, reducing the mr to trace.On (b)(6) 2024, a follow up transesophageal echocardiogram (tee) was performed and revealed that the previously implanted clip had partially moved off the posterior mitral leaflet (pml), causing the mr to increase to a grade of 3.
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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 migration appears to be related to patient morphology/pathology.The recurrent mr appears to be related to the partial clip movement.Mr is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment/intervention was provided.There is no indication of a product issue with respect to manufacture, design, or labeling.
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