ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
Received Oct 20, 2021 · Event occurred Sep 9, 2021
Report 3011706110-2021-00045 · MDR key 12666869
Device
Generic name
Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Clip
Manufacturer
Atricure, Inc.Model number
PRO240Catalog number
A000966
Lot number
UNKNOWN
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Not reported
- Cardiac Perforation
- Cardiac Perforation
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT UNDERWENT AN ON-PUMP OPEN STERNOTOMY LVAD (LEFT VENTRICULAR ASSIST DEVICE) WITH LEFT ATRIAL APPENDAGE MANAGEMENT. WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE PRO240 CLIP, THE LEFT ATRIAL APPENDAGE WAS INJURED BY THE DISTAL TIP OF THE CLIP. THE SURGEON REMOVED THE PRO240 CLIP AND A SECOND CLIP, AN ACHV40 WAS PLACED WHICH MANAGED THE PERFORATION. THE LVAD WAS COMPLETED AND PATIENT WAS STABLE POST PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.