AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Jul 25, 2025 · Event occurred Jul 1, 2025
Report 2017865-2025-95938 · MDR key 22611845
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Product problems
- Improper or Incorrect Procedure or Method
- Adverse Event Without Identified Device or Use Problem
- Improper or Incorrect Procedure or Method
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Valvular Insufficiency/ Regurgitation
- Valvular Insufficiency/ Regurgitation
Narrative
Description of Event or Problem
NEW INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT OPEN-HEART SURGERY AND HAD ITS VALVE REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Additional Manufacturer Narrative
FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED YET.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR DEVICE EXTRACTION PROCEDURE. DURING THE PROCEDURE, A RETRIEVAL CATHETER WAS USED AGAINST INSTRUCTIONS FOR USE GUIDELINES TO EXTRACT A COMPETITOR'S DEVICE. THE DEVICE WAS SUCCESSFULLY EXTRACTED; HOWEVER, IT WAS NOTED THAT A PIECE OF CORDEA TENDINEAE CAME OUT AS WELL. AS A RESULT, THE PATIENT EXPERIENCED SEVERE TRICUSPID REGURGITATION POST-PROCEDURE. NO INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS STABLE.