It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and a prolapsed anterior mitral leaflet for a mitraclip procedure.After retracting the dilator and guide wire from the steerable guide catheter (sgc), air bubbles were observed in the left atrium via echocardiogram.There was no leak or air bubbles observed from the sgc.Electrocardiogram (ecg) changes and a blood pressure drop was observed due to the air bubbles.The air bubbles were resolved with additional aspiration and the procedure continued.Two mitraclips were implanted, and the mr was reduced to grade 1.There were no adverse patient sequalae or clinically significant delay.
|
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.The investigation was unable to determine a cause for the reported air embolism.The reported hypotension and non specific ekg/ecg changes appear to be cascading effects of the air embolism.Air embolism, hypotension, and non specific ekg/ecg changes are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance as additional aspiration was performed.There is no indication of a product issue with respect to manufacture, design, or labeling.
|