MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-010-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Stroke/CVA (1770); Cardiac Tamponade (2226); Cognitive Changes (2551); Pericardial Effusion (3271); Syncope/Fainting (4411); Movement Disorder (4412)
Date of Event	08/08/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer amulet delivery sheath.Transseptal puncture was inferior and mid.The patient's activated clotting time (act) level was 250 seconds.The left atrial pressure was 11mmhg.Heparin was administered.The device was implanted.Protamine was administered.On (b)(6) 2026 the patient was found unresponsive and was transported to the emergency room of a different hospital.The patient had a low systolic blood pressure in the 60's at the nursing facility but was in the 100's upon admission.The patient was unable to speak and was confused, indicative of a stroke.A chest x-ray demonstrated cardiomegaly and a watchman that was also implanted the day prior.Computed tomography angiography revealed a high-density pericardial effusion with cardiac tamponade.A pericardiocentesis was planned; however during preparation, the patient went extremely bradycardic and within a minute or so passed away.The cause of death was cardiac arrest.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50615786
• Report Number: 2135147-2026-06007
• Device Sequence Number: 16137973
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)310228(10)11326318
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 11326318
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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: Disability; Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Race: White