The device was not returned for analysis.A review of the lot history record did not identify any manufacturing nonconformities issued to the reported lot that could have contributed to the reported event.Based on the information reviewed and without the device to analyze, a definite cause for the reported thrombosis could not be determined.The reported patient effect of emboli (thrombus) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures there is no indication of a product quality issue with respect to manufacture, design or labeling.
|
This is filed to report thrombus.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc) was inserted without issues; however, while at the septum, thrombus was noticed in the right atrium (ra) attached to the dilator.It was noted that the activated clotting time (act) remained above 250 throughout the procedure.The sgc was removed and a 14f sheath was inserted in an attempt to aspirate the thrombus.The thrombus was successfully removed.The sgc was attempted to be re-prepared; however, the sgc came in contact with the iv pole.Therefore, the sgc was not used and was replaced.Two clips were successfully implanted, reducing mr to a grade of 2+.There was no clinically significant delay in the procedure.No additional information was provided.
|