MAUDE Adverse Event Report: ABBOTT MEDICAL (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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implantation of a right ventricular leadless pacemaker (rvlp), the physician experienced difficulty navigating the device to the right ventricle.After the device crossed the tricuspid valve and was untethered, echocardiography revealed severe tricuspid regurgitation.It was suspected that the rvlp could be interacting with the valve.It was also suspected that the septal leaflet of the tricuspid valve had been damaged during the procedure.The rvlp remains implanted.During removal of the introducer, tissue was observed on the introducer.The patient was recovering following the procedure.

• Brand Name: AVEIR¿ INTRODUCER KIT ¿ 50 CM
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25713649
• Report Number: 2017865-2026-14137
• Device Sequence Number: 21487514
• Product Code: DYB
• UDI-Device Identifier: 05415067034847
• UDI-Public: (01)05415067034847(10)11289622(17)290228
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2026

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: 11289622
• 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: 06/12/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2026
• 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: Other
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 30 KG