It was reported that a mitraclip procedure was performed to treat a degenerative mitral regurgitation (mr) with grade of 4.During preparation, when testing establish final arm angle (efaa) on the bench, the clip jumped open to 25-30 degrees.The clip was unlocked, opened and locked at 60 degrees and then fully closed.Efaa was tested again, and the clip would still open to 25-30 degrees.The clip was not used, and a replacement was used to complete the procedure.One clip was implanted with no reported issue, reducing mr to grade 2.There was no clinically significant delay in the procedure and no adverse patient effects.
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All available information was investigated and the reported unintended movement of clip open during efaa and difficult to open or close (clip jumping) could not be confirmed via returned device 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 conclusive cause for the reported unintended movement of clip open during efaa and difficult to open or close (clip jumping).There is no indication of a product issue with respect to manufacture, design, or labeling.
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