It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and placed on the mitral valve.However, while grasping and before deployment, it was observed the clip was open and unable to close.It was noted the clip remained opened to roughly 30-40 degrees.Therefore, troubleshooting was performed; the lock was tested, and the clip was noted to not open any further.The clip was then deployed.To stabilize the clip, two additional clips were successfully implanted, reducing mr to a grade of 1-2.There was 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, the cause of the reported unable to close and unable to open clip were unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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