All available information was investigated, and the reported difficult to open or close (gripper actuation - single) and break (gripper line) was confirmed via returned device analysis.The reported positioning failure (leaflet grasping - clip not implanted) and difficult to remove (anatomy) could not be replicated in a testing environment.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.Based on available information and the results of analysis, the reported difficult to open or close (gripper actuation - single), associated with a gripper¿s inability to raise, appears to be due to the gripper line break.The gripper line break appears to be due to the gripper interacting with the chordae.The reported difficult to remove (anatomy), associated with the clip implant interaction with chordae, was due to procedural circumstances while retracting the clip back to left atrium.The reported positioning failure (leaflet grasping - clip not implanted), associated with the inability to grasp, was due to challenging anatomy with leaflet restriction and tissue thickening.The reported tissue injury (chordal rupture) appears to be due to the clip implant interacting with chordae and the attempt to free from the chordae.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and grasping was performed.However, the leaflets were unable to be grasped.When retracting the clip into the left atrium (la), the clip was caught in the chordae.After freeing the clip from the chordae, it was noticed that one of the grippers remained down while the gripper levers were retracted.Therefore, the clip was removed and replaced.While outside the anatomy, it was observed that one of the grippers lines had disconnected.An xt clip was inserted, but prior to grasping, a chordal rupture was observed.It was suspected to be caused by the xtw clip.The xt clip was then deployed, reducing mr to a grade of 3.No clinically significant delay in the procedure.
|