ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
Received May 13, 2022 · Event occurred Apr 13, 2022
Report 3011706110-2022-00017 · MDR key 14394557
Device
Generic name
Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Clip
Manufacturer
Atricure, Inc.Model number
PRO240Catalog number
A000966
Lot number
MF1152A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Thrombosis/Thrombus
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
ON (B)(6) 2022 A PATIENT UNDERWENT A ROBOTIC CRYO MAZE WITH CONCOMITANT LEFT ATRIAL APPENDAGE MANAGEMENT. PRIOR TO CLIP PLACEMENT, THE PHYSICIAN NOTICED A THROMBUS IN THE LAA, BUT PROCEEDED WITH THE PROCEDURE. THE CLIP WAS DEPLOYED AND DURING DEPLOYMENT THE THROMBUS MIGRATED INTO THE LEFT ATRIUM AND THEN OUT OF THE ATRIUM INTO THE BODY. POST-PROCEDURE, THE CLOT EMBOLIZED TO LEFT KIDNEY AND WAS REMOVED IN A FOLLOW-UP PROCEDURE. THE PATIENT IS DOING WELL AND THERE WERE NO LONG-TERM COMPLICATIONS. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTION.
Additional Manufacturer Narrative
CASE (B)(6) THE PRO240 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER MF1152A. 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.