It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a posterior prolapse.A steerable guide catheter (sgc) (31102r1036) and an xtw clip (31016r1083) were inserted and advanced to the mitral valve.It was noted inserting the clip into the sgc was difficult as resistance was felt when inserting and lining up the blue alignment markers.However, bubbles were observed in the left atrium (la) and in the chamber of the sgc.It was noted the three-way stop cock had not been fully closed on the sgc.Therefore, the clip was removed, and aspiration was performed which removed the air from the anatomy.It was noted the lock lever caps were turned more than half a turn in the open direction to de-air the clip delivery system (cds).The clip was then re-inserted and deployed.A second xtw clip was successfully implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.
|
The device was not returned for analysis.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.The investigation determined the reported user error (improper or incorrect procedure or method) was due to the stopcock not fully closed during the procedure.The reported leak appears to be related to the reported user error (improper or incorrect procedure or method).It should be noted the mitraclip system g4 instruction for use (ifu), instructs to "close the guide stopcock." the reported air embolism appears to be related to the reported leak.Air embolism is listed in the ifu as a known possible complication associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
|