ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIP

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER, A DEVICE HISTORY REVIEW WAS CONDUCTED AND THERE IS NOTHING IN THE PRODUCT HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE SUBJECT COMPLAINT.

Description of Event or Problem

A PATIENT UNDERWENT A MINIMALLY INVASIVE CARDIAC SURGERY MITRAL VALVE REPAIR (MICS-MVR) WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE). DURING REWARMING, AFTER COMPLETION OF THE PLANNED PROCEDURE, THE ARTERIAL PRESSURE FAILED TO RISE. BASED ON ECG FINDINGS, IT WAS SUSPECTED THAT THE IMPLANTED ATRICLIP WAS COMPRESSING A CORONARY ARTERY. THE PROCEDURE WAS CONVERTED TO A MEDIAN STERNOTOMY, AND THE CLIP WAS REMOVED. NO ADDITIONAL INTERVENTION WAS PERFORMED ON THE LEFT ATRIAL APPENDAGE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT HARM WAS REPORTED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.