This is filed to report the clip opening while locked (00210u143).It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).The first clip (00210u143) was placed in a2/p2.After checking the final arm angle when attempting to remove the lock line, both ends became tangled.Scissors were used to cut the tangled portion.When attempting to remove the lock line, it was observed, that the clip was open at 60 degrees.The clip was re-closed following the troubleshooting process.The clip was confirmed to stay closed and was implanted, mr reduced to 1-2.To further reduce mr, a second clip (00402u266) was advanced.When attempting to open the clip in the left atrium, the clip did not open.After repeated troubleshooting, the clip could not be opened and was removed.The patient's circulation was inadequate due to the prolonged anesthesia; therefore, the procedure was aborted.Mr was reduced to 1-2.No additional information was provided.
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The device was returned and investigated.The reported tangled lock line and clip opened while locked could not be tested 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 did not indicate a lot-specific quality issue.The reported patient effect of diminished pulse, as listed in the mitraclip nt system (g2) (jpn) instructions for user, is a known possible complication associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the reported tangled lock line and clip opened while locked.The patient effect of diminished pulse was due to procedural conditions.The reported delayed therapy/non-surgical treatment was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.
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