All available information was investigated, and the reported single gripper actuation issue was confirmed via returned device analysis.The reported difficult to remove (anatomy) and difficult imaging could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.Additionally, the gripper line was observed to be broken and l-lock tabs were observed to be bent.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, the cause of the reported difficult to remove (anatomy) was unable to be determined.The observed broken gripper line and bent l-lock tabs are likely a result of troubleshooting the reported difficult to remove (anatomy).The reported single gripper actuation issue is a cascading event of the observed broken gripper line.The reported difficult imaging was due to challenging patient anatomy (rotated heart and enlarged atrium).The reported tissue injury is a cascading event of the reported difficult to remove (anatomy).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 degenerative mitral regurgitation (mr) with a grade of 3 with an enlarged atrium and a rotated heart.It was noted that there was difficulties visualizing during the procedure.An xtw clip was inserted and grasping was performed.However, the clip became caught in chordae.Troubleshooting was performed and the clip was removed from chordae.Once removed, a gripper actuation issue was observed.The physician then decided to remove the clip and replace it.Upon removal, it was observed tissue damage had occurred.One clip was then successfully implanted, reducing the mr to a grade of 1.No clinically significant delay in the procedure.
|