It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4.A xtw mitraclip (lot 331012r1092)) was advanced to the valve and grasped successfully.Deployment procedure was performed, with the first establishment of final arm angle (efaa) being successful.After the lock line was removed, the clip popped open to 90 degrees.The clip was re-closed and was released from the delivery system.After release, the clip popped open again to 110 degrees.The grippers were moving synchronized with the leaflets.A second xtw mitraclip (lot: 31012r1094) was then implanted successfully, reducing mr to grade 2.There was no clinically significant delay.
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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.The investigation was unable to determine a cause for the reported unintended movement of clip open while locked and clip jumping.The reported partial clip movement (clip moving) appears to be a cascading effect of the clip open while locked.The unexpected medical intervention was a result of case-specific circumstance as an additional clip was implanted.There is no indication of a product issue with respect to manufacture, design, or labeling.
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