ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEM
Received May 14, 2026 · Event occurred Apr 16, 2026
Report 3011706110-2026-00024 · MDR key 25172950
Device
Generic name
Left Atrial Appendage Clip, Implantable
Manufacturer
Atricure, Inc.Model number
ACHM50Catalog number
A001406
Lot number
158595
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) AND AORTIC VALVE REPLACEMENT/REPAIR (AVR) VIA MEDIAN STERNOTOMY WITH CONCOMITANT TAMPA 2 SURGICAL ABLATION LESION SET AND LEFT ATRIAL APPENDAGE EXCLUSION (LAAE). AN INCISION WAS MADE IN THE LEFT ATRIAL APPENDAGE (LAA) FOR ACCESS TO PERFORM THE TAMPA 2 LESION SET, WHICH WAS COMPLETED AS PLANNED. AN ACHM50 ATRICLIP DEVICE WAS DEPLOYED AFTER THE CONCOMITANT SURGICAL ABLATION PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS TRANSFERRED TO THE OPEN-HEART RECOVERY UNIT BUT WAS SUBSEQUENTLY RETURNED TO THE OPERATING ROOM DUE TO BLEEDING. UPON EVALUATION, THE SURGEON IDENTIFIED A SMALL LEAK AT THE LAA OSTIUM, NEAR THE SITE OF THE ACCESS INCISION. THE LAA WAS OVERSEWN, AND THE PATIENT RECOVERED WITHOUT FURTHER REPORTED COMPLICATIONS.