It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, prolapsed posterior mitral leaflet, and dilated left atrium.A mitraclip ntw was implanted and then a mitraclip xtw was implanted without issues, reducing the mr to a grade of 1.On (b)(6) 2024, an echocardiogram was performed and revealed that the second clip (the mitraclip xtw) had detached off of the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 3.In the physician's opinion, a tear likely occurred.
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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.Based on available information, the cause of the reported 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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