It was reported that a mitraclip procedure was performed on (b)(6) 2024, to treat degenerative mitral regurgitation (mr) grade 4+.A xtw lot: 30915a1079 was implanted laterally reducing mr to grade 2+.A second xt mitraclip (lot:30502r1062) was then placed laterally.During capturing attempts, the xtw clip was observed to be detached from the anterior leaflet (single leaflet device attachment (slda)).No contact between the two clips was observed.The xt was then implanted to stabilize the slda, along with a nt mitraclip (lot: 30831r1106).Fourth clip ntw (30425r1013) was then implanted to further reduce mr.The procedure ended with mr reduced to grade 1.In the physician's opinion the slda was related to the patient's redundant posterior leaflet.
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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 reported slda was due to challenging patient anatomy.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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