MAUDE Adverse Event Report: ABBOTT AVEIR¿ RETRIEVAL SYSTEM CATHETER; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	LSCR111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: AVEIR¿ RETRIEVAL SYSTEM CATHETER
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22786671
• Report Number: 2017865-2025-97401
• Device Sequence Number: 15929477
• Product Code: MMX
• UDI-Device Identifier: 05415067034496
• UDI-Public: (01)05415067034496(10)10474662(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: LSCR111
• Device Lot Number: 10474662
• Was Device Available for Evaluation?: No
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Sex: Unknown