AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Sep 13, 2024
Report 2017865-2024-64878 · MDR key 20213680
Device
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
NA · Unknown
- Arrhythmia
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Arrhythmia
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT AN ADDITIONAL SURGERY WAS PERFORMED TO REPAIR THE VALVE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE. THE LP WAS POSITIONED IN THE LOWER SEPTUM AND WHILE PERFORMING A DEFLECTION TEST, THE LP WAS MOVING MORE THAT DESIRED WHILE THE PATIENT WAS EXPERIENCING EXTRASYSTOLES. THE LP WAS RELEASED FROM THE DELIVERY CATHETER, HOWEVER THE MOVEMENT WAS NOT RESOLVED. A RETRIEVAL CATHETER WAS DEPLOYED TO EXPLANT THE LP. WHILE ATTEMPTING TO RETRIEVE THE LP THE RETRIEVAL CATHETER PROTECTIVE SLEEVE FILLED WITH FLUID. IT WAS THEN OBSERVED THAT THE TRICUSPID VALVE WAS DAMAGED AND THE LP HELIX WAS STRETCHED. THE LP WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Additional Manufacturer Narrative
B3 - THE ESTIMATED EVENT DATE IS AUG 2024. D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER CANNOT BE PROVIDED AS A PRODUCT IDENTIFIER COULD NOT BE OBTAINED.
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.