AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Nov 17, 2025 · Event occurred Oct 28, 2025
Report 2017865-2025-1005204 · MDR key 23575064
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot number
10777996
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Cardiac Perforation
- Pericardial Effusion
- Low Blood Pressure/ Hypotension
- Cardiac Perforation
- Pericardial Effusion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER RIGHT VENTRICLE LEADLESS PACEMAKER (RVLP) IMPLANTATION A RIGHT VENTRICULOGRAPHY WAS PERFORMED AND REVEALED THAT THE HELIX HAD PROTRUDED OUTSIDE THE HEART AT THE APEX. IT WAS NOTED THAT THE RVLP DID NOT ROTATE DURING SCREWING. AFTER REMOVAL, THE PATIENT'S VITAL SIGNS DETERIORATED, AND AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED PERICARDIAL EFFUSION. DRAINAGE WAS CARRIED OUT, AND FRESH FROZEN PLASMA WAS ORDERED, NO IMPROVEMENT IN VITAL SIGNS WERE OBSERVED SO AN EXTRACORPOREAL MEMBRANE OXYGENATION TREATMENT WAS INITIATED AND THE VITAL SIGNS TEMPORARILY STABILIZED. THE PATIENT'S VITAL SIGNS DETERIORATED AGAIN, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT PASSED AWAY LATER THAT DAY.
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.