It was reported that on 0(b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, flail, calcified posterior leaflet and a prolapsed posterior.One clips was implanted, reducing mr to a grade of the following day, echocardiography showed signs of the implanted clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 3-4.On 21march2024, another echocardiography confirm that there was an slda of the posterior leaflet.It was noted that there was a new indentation where the clip was implanted.Mr remains at a grade of 3-4.
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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 did not indicate a lot-specific quality issue.Based on available information, the cause of the slda and tissue injury were unable to be determined.The reported recurrent mr was a cascading event of the reported slda.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 serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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