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

Model Number	LSCR111
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information was requested but not received.D4 - primary unique device identification (udi) number cannot be provided as a product identifier could not be obtained.
Event or Problem Description
It was reported that after the leadless (lp) pacemaker implant was completed, the patient experienced cardiac arrest resulting in pulseless heart activity.A thoracotomy and cardiac massage were performed.During the cardiac massage, the lp dislodged and migrated to the pulmonary artery.The lp was unable to be retrieved with a retrieval catheter due to a stretched helix.The pacemaker was surgically removed.The patient was alert with normal vital signs following the procedure, however, passed away a few days later.The physician alleged the patient passed away due to a pulmonary embolism and the procedure time may have contributed to the patient's passing.The physician alleged that the abbott products used were not related to the cardiac arrest or the patient death.Additionally, it was stated that the patient experienced a pleural effusion.It is unknown if the pulmonary embolism or pleural effusion was related to the abbott products or the procedure.
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: 22462311
• Report Number: 2017865-2025-91753
• Device Sequence Number: 8560107
• Product Code: MMX
• UDI-Device Identifier: 05415067034496
• UDI-Public: (01)05415067034496(10)10487372(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,Followup
• Report Date (Section B): 12/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: LSCR111
• Device Lot Number: 10487372
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 12/18/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/18/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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; Death
• Patient Sex: Unknown