MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Model Number	9-ACP2-010-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/11/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was implanted using an 14f amulet delivery system.The implantation was reported as successful.Approximately, 10 minutes after completion of the device implantation, the patient experienced clinical deterioration and required resuscitation.Resuscitative efforts were continued for approximately 25 minutes; however, these efforts were unsuccessful, and the patient was pronounced deceased.The reported cause of death was right heart failure.The cause of death was identified as complete right ventricular failure presenting as right heart failure, with a suspected right ventricular infarction.Additionally, the implanter classified the death as likely related to the procedure and the patient¿s comorbidities rather than to the performance of the implanted device.
Additional Manufacturer Narrative
An event of a cardiac arrest and death were reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported cardiac arrest and death could not be determined.An unexpected medical intervention was a result of case specific circumstances, as resuscitation efforts were performed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25 mm amplatzer amulet was implanted using an 14f amulet delivery system.The implantation was reported as successful.The procedure was reported to have been performed in accordance with the instructions for use (ifu), and all required criteria were fulfilled.Approximately 10 minutes after completion of the device implantation, the patient experienced clinical deterioration and required resuscitation.Resuscitative efforts were continued for approximately 25 minutes; however, these efforts were unsuccessful, and the patient was pronounced deceased.The reported cause of death was right heart failure.The cause of death was identified as complete right ventricular failure presenting as right heart failure, with a suspected right ventricular infarction.There were reported to be no complications related to the occluder device.Additionally, the implanter classified the death as likely related to the procedure and the patient's comorbidities rather than to the performance of the implanted device.

• Brand Name: AMPLATZER AMULET
• Common Device Name: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24780445
• Report Number: 2135147-2026-02161
• Device Sequence Number: 9925772
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300430(10)10876368
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 9-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 10876368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 06/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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: Disability; Required Intervention; Death
• Patient Sex: Unknown