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 did not indicate a lot-specific quality issue.Based on available information, the cause of the reported slda was unable to be determined.The reported recurrent mr was a cascading event of the reported slda.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization 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 (b)(6) 2024, a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) grade 4 with prolapsed posterior leaflet.One clip was implanted with no reported issue, reducing mr to grade 1.On (b)(6) 2024, the clip was observed to detach from the posterior leaflet (single leaflet device attachment (slda)).The mr increased to grade 4.On (b)(6) 2024, additional mitraclip was performed to stabilize the slda.One xtw clip was implanted, reducing mr from grade 4 to grade 2-3.
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