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

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO DEVICE MALFUNCTION WAS ALLEGED.¿ THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.

Description of Event or Problem

A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGICAL PROCEDURE VIA MEDIAN STERNOTOMY WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE). AN ATRICLIP DEVICE (MODEL ACH2, SIZE UNKNOWN) WAS PLACED; INTRAOPERATIVE ASSESSMENT IDENTIFIED IMPINGEMENT OF THE LEFT MAIN CORONARY ARTERY (LMCA) BY THE CLIP, AND THE DEVICE WAS REMOVED. THE LMCA COMPROMISE PERSISTED. THE PATIENT EXPERIENCED CARDIAC ARREST, REQUIRING EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO), AFTER WHICH CORONARY ANGIOGRAPHY WAS PERFORMED, WHICH CONFIRMED ONGOING LMCA COMPROMISE. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS NOT PERFORMED DUE TO CONCERN OF POTENTIAL FOR DISTAL EMBOLIZATION. THE PATIENT EXPIRED ON THE FOURTH POST-OPERATIVE DAY; NO AUTOPSY WAS PERFORMED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THIS ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.