ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIP
Received May 7, 2026 · Event occurred Apr 7, 2026
Report 3011706110-2026-00022 · MDR key 25117186
Device
Generic name
Left Atrial Appendage Clip, Implantable
Manufacturer
Atricure, Inc.Model number
PRO250Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Thrombosis/Thrombus
Narrative
Additional Manufacturer Narrative
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 A STANDALONE THORACOSCOPIC LEFT ATRIAL APPENDAGE EXCLUSION USING AN ATRICLIP DEVICE. ON POSTOPERATIVE DAY ONE, AN EMBOLIZATION OF A THROMBUS TO THE LEG WAS IDENTIFIED. A THROMBECTOMY WAS PERFORMED, AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION POSTOPERATIVELY. PERIOPERATIVE IMAGING WAS REQUESTED BUT COULD NOT BE OBTAINED. WHILE DIRECT CAUSE OR CONTRIBUTION BY THE DEVICE WAS NOT CONFIRMED, IT CANNOT BE RULED OUT; THEREFORE THIS EVENT IS BEING REPORTED PER PART 803. THERE IS NO REPORTED DEVICE MALFUNCTION, AND THIS ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.