It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+ and a rotated heart.A mitraclip xt was inserted and placed on the valve.However, while establishing final arm angle (efaa), it was observed that the clip continuously opened.The clip was noted to have jumped fully open.Troubleshooting was performed but was not successful.Therefore, the clip was removed from the patient.The procedure was completed with two clips implanted.The mr was reduced to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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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 and without the device to analyze, a cause of the reported unintended movement (clip open during efaa, establish final arm angle) could not be determined.The reported difficult to open or close (clip jumping) appears to be due to the unintended clip opening as the clip lock disengaged during efaa, resulting in a sudden release of tension in the actuator mandrel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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