MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD201
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for initial implant procedure on (b)(6) 2026.Upon fixation during procedure, the right atrial (ra) leadless pacemaker (lp) exhibited intermittent high threshold, low sensing of p-wave, and decreased pacing impedance.Repositioning was attempted, but the ralp was difficult to be re-docked to the delivery catheter.Eventually, the ralp was able to be re-docked, and repositioned.Ralp helix was visually examined outside of the body, and no issue was noted.The ralp was implanted as a result.Upon cardiac ultra-sound imaging post-procedure, it was found that the patient had developed a pericardial effusion due to a cardiac perforation.The patient was transferred to an intensive care unit with a chest tube inserted for the effusion.No further intervention was performed.Patient condition was stable.
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¿ 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: 50510036
• Report Number: 2017865-2026-18236
• Device Sequence Number: 10709593
• Product Code: PNJ
• UDI-Device Identifier: 05415067038487
• UDI-Public: (01)05415067038487(10)11429216(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: LSCD201
• Device Catalogue Number: LSCD201
• Device Lot Number: 11429216
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2026
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown