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

Model Number	9-ACP2-010-025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/05/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains 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) 2026, a 25mm amplatzer amulet was chosen for implant using a 14f amplatzer amulet delivery system.The patient¿s condition prior to the procedure was reported as normal with no abnormalities, and no pericardial effusion was noted prior to the procedure.The patient was in atrial fibrillation, was taking oral anticoagulation, and received heparin (10,000 ie) during the procedure, with an activated clotting time of greater than 250 ms.The transseptal puncture was performed at the inferior/posterior location.During the procedure, a wire was placed in the left atrial appendage, and the device was partially recaptured once; however, no difficulties or multiple manipulations, and no multiple wire or sheath exchanges, were reported.A few hours after successful implantation of the amulet occluder, a circumferential pericardial effusion developed, and the physicians reported the presence of cardiac tamponade.Pericardiocentesis was performed to address the effusion.The implanter indicated that the event was likely related to the procedure, although they believed that the amulet device caused the pericardial effusion.The patient subsequently went into cardiogenic shock due to the pericardial effusion, and death occurred on (b)(6) 2026.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was chosen for implant using a 14f amplatzer amulet delivery system.The patient¿s condition prior to the procedure was reported as normal with no abnormalities, and no pericardial effusion was noted prior to the procedure.The patient was in atrial fibrillation, was taking oral anticoagulation, and received heparin (10,000 ie) during the procedure, with an activated clotting time of greater than 250 ms.The transseptal puncture was performed at the inferior/posterior location.During the procedure, a wire was placed in the left atrial appendage, and the device was partially recaptured once; however, no difficulties or multiple manipulations, and no multiple wire or sheath exchanges, were reported.A few hours after successful implantation of the amulet occluder, a circumferential pericardial effusion developed, and the physicians reported the presence of cardiac tamponade.Pericardiocentesis was performed to address the effusion.The implanter indicated that the event was likely related to the procedure, although they believed that the amulet device caused the pericardial effusion.The patient subsequently went into cardiogenic shock due to the pericardial effusion, and death occurred on (b)(6) 2026.
Additional Manufacturer Narrative
An event of patient-device incompatibility, 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 specifications.Based on the information received, the cause of the reported patient-device incompatibility, pericardial effusion, and cardiac tamponade could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances as the pericardiocentesis was performed.

• 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: 24550735
• Report Number: 2135147-2026-01490
• Device Sequence Number: 9377647
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300228(10)10769425
• 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): 06/04/2026

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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 10769425
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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; Death
• Patient Sex: Unknown