MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ RETRIEVAL SYSTEM CATHETER; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	LSCR111
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2025-1004968.It was reported that a patient presented for a right atrial leadless pacemaker (lp) explant procedure.Patient had complained about chest pain possibly related to premature ventricular contractions or high capture thresholds.During the explant, the tri-loop snare detached from the retrieval catheter.The snare was successfully retrieved, but the rest of the procedure was aborted and the lp remained implanted.Patient was stable.
Additional Manufacturer Narrative
The reported event of ¿the integrated tri-loop snare separated from the retrieval catheter¿ was confirmed.As received, a complete catheter was returned without the tri-loop snares.Visual and x-ray inspection found the tri-loop snare detached from the catheter¿s distal tip.The cause of the reported event was isolated to the damaged catheter consistent with procedural damage.Abbott is continuing to monitor this issue.

• Brand Name: AVEIR¿ RETRIEVAL SYSTEM CATHETER
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23548008
• Report Number: 2017865-2025-1004971
• Device Sequence Number: 9683358
• Product Code: MMX
• UDI-Device Identifier: 05415067034496
• UDI-Public: (01)05415067034496(10)10518009(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K213494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: LSCR111
• Device Lot Number: 10518009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown