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 was unable to be determined.The reported unexpected medical intervention 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 that on (b)(6) 2017, a mitraclip procedure was performed to treat mitral regurgitation (mr).One nt mitraclip (lot: unk) was implanted successfully.Recently the patient developed dyspnea and heart failure symptoms due to severe recurrent mr grade 4+.The recurrent mr was due to the progression of the patient's heart failure.The nt mitraclip remained stable on the leaflets with no tissue or chordal damage.On (b)(6) 2024, a mitraclip intervention procedure was performed.Ntw lot: 30911r1040 was implanted.After deployment, the clip detached from the anterior leaflet.An additional mitraclip nt lot: 30808r2100 was implanted to stabilize the slda and reduce mr to grade 1-2.There was no clinically significant delay.
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