inforMED
MalfunctionPZX

PENDITUR LAA EXCLUSION SYSTEM

Received Oct 8, 2025 · Event occurred Apr 13, 2025

Report MW5176986 · MDR key 23244605

Device

Generic name

Left Atrial Appendage Clip, Implantable

Model number

LAAC45

Lot number

T4J029X

Product problems

  • No Flow

Patient

76 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

TEE DEMONSTRATED FLOW INTO THE LEFT ATRIAL APPENDAGE AFTER LEFT ATRIAL APPENDAGE LIGATION CLIP WAS PLACED. AT TIME OF INSERTION, THE CLIP WAS PLACED AND THERE WAS NO FLOW INTO THE LEFT ATRIAL APPENDAGE.