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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Heart Block (4444)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amulet was chosen for implant during a left atrial appendage occlusion (laao) procedure.The left atrial appendage (laa) was described as complex with significant pectinate muscles.Measurements indicated an ostium size of 22¿33 mm and a landing zone of 21¿24 mm, and sizing supported the selection of a 28 mm amulet device.After deployment of the 28 mm device, a small residual gap was observed on the mitral side.As a result, a 31 mm amplatzer device was selected as a replacement and implanted using an unknown delivery system.Following implantation, the gap was no longer present, closure criteria were met, and the device was released.Several hours later, the recovery unit reported that the patient had developed third-degree heart block, prompting physician review.A chest x-ray and transthoracic echocardiogram (tte) were ordered.The tte was inconclusive; however, the chest x-ray indicated that the device was not in its expected position.A ct scan was subsequently performed and confirmed that the device had embolized into the aorta.The team proceeded with retrieval, and the device was successfully removed via snare from the descending aorta.No patient harm or complications were reported.The patient was noted to be doing well post-procedure, with no ongoing issues.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An even of device embolization, atrial fibrillation, and heart block was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device embolization could not be determined.The reported atrial fibrillation was likely a cascading effect from the event.The reported heart block was likely related to the blockage of blood flow caused by the device embolization, however this cannot be determined.An unexpected medical intervention was a result of case specific circumstances, as the device was removed via snare.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 24226248
• Report Number: 2135147-2026-00553
• Device Sequence Number: 13103006
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)290831(10)10499189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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,Followup
• Report Date (Section B): 04/09/2026

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 10499189
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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
• Patient Age: 74 YR
• Patient Sex: Male