MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ INTRODUCER KIT ¿ 50 CM; INTRODUCER, CATHETER

Model Number	LSN25501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, the right ventricular leadless pacemaker was inadequately fixated.After fixating, loss of sensing was observed.Fluoroscopy imaging showed that the device had dislodged and migrated to the right pulmonary artery/lung.Retrieval of the device was attempted.While retrieving, the device's helix got stuck to the pulmonic valve.An introducer was utilized to attempt removing the device, and by doing so its helix was stretched.It was then when the patient's blood pressure dropped, and a pericardial effusion was observed via echocardiogram.Cardiac tamponade was noted as well.Pericardiocentesis was performed, and the patient was stabilized.The device was retrieved, and the patient was in stable condition post-procedure.
Additional Manufacturer Narrative
Correction to add device history review (dhr).A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: AVEIR¿ INTRODUCER KIT ¿ 50 CM
• Common Device Name: INTRODUCER, CATHETER
• 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: 23759677
• Report Number: 2017865-2025-1006909
• Device Sequence Number: 13294811
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)10817110(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K211989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Model Number: LSN25501
• Device Lot Number: 10817110
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male