It was reported that a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) with grade of 4, posterior flail, prolapsed posterior leaflet, dilated left atrium.The mitraclip system was prepared as per instruction for use (ifu) and functioned as intended.During the procedure, the clip was inverted for re-alignment and attempt to get back into the atrium.Echocardiogram showed that one gripper did not raise and remained at 120 degrees.During re-positioning, the clip was caught in chordae and was able to be freed with standard troubleshooting but was noted to be difficult.It was noted that the cds was curved to approximately 110 degrees.After removal, the clip was inspected, showing that the gripper line was not on the gripper but had been pulled into the system.A replacement device was used to complete the procedure.Two clips were implanted, reducing mr to grade 3.There was no clinically significant delay in the procedure and no adverse patient effects.
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All information was investigated, and the returned device analysis confirmed the reported single gripper actuation issue and gripper line break.The reported improper or incorrect procedure or method-failure to follow steps / instructions and difficult or delayed positioning - anatomy could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and while the reported single gripper actuation issue appears to be related to the gripper line break, a cause for how the gripper line broke could not be determined.Difficult or delayed positioning associated with the clip interacting with the anatomy appears to be related to patient (dilated left atrium) and procedural conditions/user technique of re-positioning the clip.Improper or incorrect procedure or method/user error is associated with the user curving the sleeve approximately 110 degrees.There is no indication of a product issue with respect to manufacture, design or labeling.
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