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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Myocardial Infarction (1969); Syncope/Fainting (4411)
Date of Event	09/16/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on a (b)(6) 2025, a 22mm amplatzer amulet was chosen for implant using a 12f amulet delivery sheath for a left atrial appendage closure procedure.The procedure was completed without complications, and the patient was treated.Following the prescribed hospitalization period, the patient was discharged without any reported adverse events.On (b)(6) 2025, it was reported that the patient returned to the hospital in cardiac arrest a few days after discharge.Resuscitation efforts were unsuccessful, and the patient passed away.The cause of death was reported to be cardiac arrest with probably heart attack.The physician indicated that there was no association between the procedure performed using the abbott device and the patient¿s death and did not attribute the event to the product¿s performance.
Additional Manufacturer Narrative
It was reported that a patient underwent a successful left atrial appendage occlusion using a 22 mm amulet occluder.Five days post-discharge the patient presented with syncope, chest pain and cardiac arrest and could not be saved and passed away.An autopsy confirmed the presence of an acute myocardial infarction without evidence of significant coronary artery stenosis.The device remained implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Fluoroscopy and tee images demonstrated a well-positioned amulet occluder within the laa.There is no evidence of a pericardial effusion or device embolization.Based on the information available and medical review, the reported patient death is consistent with acute myocardial infarction 5 days post-procedure.However, the exact cause could not be conclusively determined.The cause of the patient effects could not be determined.There were no complaints associated with any other devices from the lot.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) 2025, a 22mm amplatzer amulet was chosen for implant using a 12f amulet delivery sheath for a left atrial appendage closure procedure.The patient¿s condition prior to the procedure was reported as permanent atrial fibrillation (af), stable, with a history of amyloid encephalopathy.The procedure was performed under transesophageal echocardiography (tee) and fluoroscopy guidance and was completed without complications.The patient remained hemodynamically stable throughout the procedure and was reported to be stable immediately post-procedure and at discharge.No ecg changes or arrhythmias were noted before discharge, and the patient was compliant with prescribed medications, including anticoagulants and antiplatelets.Following the prescribed hospitalization period, the patient was discharged without any reported adverse events.On (b)(6) 2025, it was reported that the patient returned to the hospital in cardiac arrest a few days after discharge.Prior to the cardiac arrest, the patient experienced syncope and chest pain.Resuscitation efforts were unsuccessful, and the patient passed away.The cause of death was reported to be cardiac arrest with probable heart attack.An autopsy was performed, and findings indicated acute myocardial infarction without significant coronary stenosis.The physician indicated that there was no association between the procedure performed using the abbott device and the patient¿s death and did not attribute the event to the product¿s performance.

• 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: 23881821
• Report Number: 2135147-2025-07637
• Device Sequence Number: 15858801
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300228(10)10753817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/25/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10753817
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 12F AMULET DELIVERY SHEATH.
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Death
• Patient Sex: Unknown