ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

Additional Manufacturer Narrative

(B)(4) - THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO DEVICE MALFUNCTION WAS ALLEGED. THE PRODUCT HISTORY RECORD WAS REVIEWED FOR LOT 119591. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

Description of Event or Problem

ON (B)(6) 2023 A 73-YEAR-OLD MALE PATIENT UNDERWENT A HYBRID (CONVERGENT APPROACH) ABLATION PROCEDURE WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY. WHILE MANIPULATING THE LEFT ATRIAL APPENDAGE WITH AN ENDOSCOPIC KITTNER AND POSITIONING THE PRO240 ATRICLIP DEVICE, BLEEDING WAS OBSERVED. THE PROCEDURE WAS CONVERTED TO MEDIAN STERNOTOMY APPROACH AND THE INJURY, LOCATED AT THE BASE OF THE PULMONARY ARTERY AND RIGHT VENTRICULAR OUTFLOW TRACT, WAS REPAIRED SUCCESSFULLY. POST-OPERATIVELY, THE PATIENT DEVELOPED SEPSIS AND EXPIRED. IT IS UNKNOWN IF AN AUTOPSY WILL BE CONDUCTED TO DETERMINE CAUSE OF DEATH. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.