MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) AVEIR¿ DELIVERY CATHETER; LEADLESS PACEMAKER

Model Number	LSCD111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/17/2026
Type of Reportable Event	Death
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.
Event or Problem Description
During an initial implant on (b)(6) 2026 of a ventricular leadless pacemaker (vlp), it was reported that the physician had difficulties accessing a suitable location for pacing.After several attempts, a location was found and the vlp was released from the delivery catheter (dc) and successfully implanted.Postoperative echocardiography revealed pericardial effusion, and the team immediately proceeded to perform a pericardiocentesis.The patient also suffered from hypotension which was resolved when the pericardial fluid was drained and the administration of blood pressure medications.There was no tamponade noted.The patient left the catheterization lab in stable condition but subsequently passed away after it was reported that her condition deteriorated.There is no allegation that the patient's death is related to any abbott products or procedures.The physician believes the patient's advanced age, and as a result, a weakened myocardium, played a major factor in the death.

• Brand Name: AVEIR¿ DELIVERY CATHETER
• Common Device Name: LEADLESS PACEMAKER
• 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: 24781275
• Report Number: 2017865-2026-06932
• Device Sequence Number: 12278114
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)11127336(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150035
• 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): 04/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 11127336
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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: Required Intervention; Death; Life Threatening
• Patient Sex: Female
• Patient Weight: 38 KG