This is filed to report the air embolism.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was advanced to the left atrium.While removing the dilator and guide wire, an air bubble was noted in the left ventricle.Abnormal ecg changes were observed and the heart rate lowered.Air aspiration was attempted and medication was administered to increase the heart rate.With the increasing heart rate, the air was pumped out of the ventricle into the aorta.The ecg and heart rate were normalized.Angiography was performed which confirmed that the air did not occlude any coronary vessels.The mitraclip procedure was continued without any issues.One clip was implanted, reducing mr to 1.A clinically significant delay was noted due to the air embolism; however, the patient was confirmed to be stable post procedure.No additional information was provided.
|
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of air embolism and arrhythmia (bradycardia) as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported changes in ekg/ecg and lowering of heart rate appear to be due to air embolism.Based on the information reviewed, a definitive cause for the reported patient effect of air embolism could not be determined.Although a conclusive cause for the reported patient effect of air embolism and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
|