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	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
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 (b)(6) 2025, a 28mm amplatzer amulet was implanted in a single deployment using a 14f amplatzer amulet torqvue delivery sheath.During the procedure, it was noted that there was difficulty crossing the septum with the sheath, but the device was deployed with only one device deployment and no recaptures.The patient¿s activated clotting time (act) levels were within 250¿300, and heparin was administered.On an unknown date, it was reported that the patient experienced pericardial effusion with cardiac tamponade and was treated.The pericardial effusion was resolved by pericardiocentesis.At the time the effusion was detected, the patient was on dapt (dual antiplatelet therapy).Wire exchanges were performed with wire positioned in the left upper pulmonary vein (lupv).The left atrial pressure at the time of the procedure was 12¿mmhg.No additional information was provided.
Additional Manufacturer Narrative
An event of pericardial effusion and cardiac tamponade 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 pericardial effusion and cardiac tamponade could not be determined.An unexpected medical intervention was a result of case specific circumstances, as a pericardiocentesis was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the 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: 23967794
• Report Number: 2135147-2026-00083
• Device Sequence Number: 4928491
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)300331(10)10804557
• 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: 2025
• 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): 03/06/2026

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: 10804557
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male