The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the thrombosis/thrombus cannot be determined.However, thrombus is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4+.When the steerable guide catheter (sgc) was in the left atrium, and the physician was trying to locate where it was, tissue flopping on the wall of the atrium was observed.The cause of the flopping tissue could not be determined.No further action was taken with the tissue.An xtw clip was advanced to valve.When maneuvering towards the valve, they saw what they thought was a thrombus on tip of the clip.Further inspection performed, but the object was gone and there was no thrombus observed.The clip was implanted successfully, reducing mr to grade 2+.Patient was fully heparinized with act over 250 seconds.There was no clinically significant delay in the procedure and no adverse patient sequelae.
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