This is filed to report a leak.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During preparation of the steerable guide catheter (sgc), a loss of fluid column occurred.This occurred multiple times; therefore, the sgc was not used and was replaced.An xtw clip was inserted and deployed on the mitral valve.However, immediately after the clip was deployed, the clip opened to roughly 25 degrees.Although the clip slightly opened, it remained stable on the leaflets.An additional clip was deployed on the mitral valve, reducing mr to a grade of 3.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leak (loss of fluid column).There is no indication of a product issue with respect to manufacture, design, or labeling.The xtw mitraclip referenced is being filed under a separate medwatch report number.
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