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 cause of the reported incomplete coaptation is due to patient anatomy (too much tension on the posterior leaflet).The reported mr and dyspnea are cascading effects of the reported incomplete coaptation.Additionally, the reported patient effects of dyspnea and mitral regurgitation are listed in the instructions for use, and 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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It was reported on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 3-4 and a restricted posterior leaflet.One xtw clip was implanted, reducing mr to a grade of on 09jan2024, the patient presented with a symptom of shortness of breath.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 4.
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