This is filed to report positioning difficulty, and a gripper actuation issue.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with posterior flail.The clip was placed on the mitral valve a2/p2, but there was no mr reduction.It was noticed that the mr was at a1/p1; however, due to mitral annular calcification (mac), it was thought that it was not possible to grasp a1/p1.The clip was repositioned lateral a2/p2, but there was no mr reduction.The clip was inverted back into the atrium, then re-crossed in a1/p1 commissure, but they were unable to grasp the leaflet due to calcium.The clip got stuck in the calcium and took 30 minutes to get out of the calcium.The clip was then tested for functionality and one gripper would not lower.The clip was pulled back into the guide per ifu and the procedure was ended with no mitraclip implanted.Mr remained at grade 4.It was noted that visualization was difficult due to patient¿s anatomy.There was no clinically significant delay in the procedure and no adverse patient effects.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 identified no similar complaints reported from this lot.Based on available information, the reported broken gripper line and clip caught in anatomy were likely due to procedural circumstances.The reported unable to lower gripper was a cascading event of the reported broken gripper line.The reported unable to grasp leaflet was due to challenging patient anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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