This is filed to report a leak and air embolism.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) 91221u160 was inserted, but air started to appear in the column.Aspiration was performed, but the air was still present.It was noted that some air may have entered the patient, causing bradycardia.To treat the bradycardia, medication was given, which returned the patient heart rate to a normal sinus rhythm.The sgc was removed and was attempted to be re-prepped; however, a loss of fluid column occurred.The device was not used and was replaced.One clip was successfully implanted, reducing mr to a grade of 2.There was no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined.The reported patient effects of air embolism and bradycardia appear to be related to the leak.The reported patient effects of air embolism and bradycardia as listed in the eifu, mitraclip ntr/xtr, are known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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