AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Aug 12, 2025 · Event occurred Jul 22, 2025
Report 2017865-2025-97401 · MDR key 22786671
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cardiac Tamponade
- Cardiac Perforation
- Pericardial Effusion
- Cardiac Tamponade
- Cardiac Perforation
- Pericardial Effusion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH COMPLAINTS OF FEVER. UPON INVESTIGATION, THE RIGHT VENTRICULAR LEADLESS PACEMAKER (LP) WAS INCORRECTLY IMPLANTED IN THE LEFT VENTRICLE DUE TO AN ATRIAL SEPTAL DEFECT. AN ATTEMPT TO RETRIEVE THE LP WAS PERFORMED WITH THE RETRIEVAL CATHETER. WHEN CROSSING THE ATRIAL SEPTAL DEFECT, A PERFORATION RESULTING IN EFFUSION AND TAMPONADE OCCURRED. THE RETRIEVAL PROCEDURE WAS ABANDONED AND PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.