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 Code	Pericardial Effusion (3271)
Date of Event	02/21/2026
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) 2026, a 25mm amplatzer amulet was implanted using a 14f amulet delivery system.No pericardial effusion was noted prior to the procedure.Transseptal access was obtained via an inferior anterior transseptal puncture, and heparin was administered during the procedure.The left atrial pressure at the time of the procedure was reported to be 10 mmhg.There was no reported difficulty with device implantation, and no multiple device manipulations were documented.During the procedure, a sheath exchange was performed in the left atrium, and a wire may have been placed in the left atrial appendage, possibly a versacross wire.On (b)(6) 2026, the patient presented with a delayed pericardial effusion, which was described as circumferential in nature.The effusion was not localized to a specific cardiac structure and was noted to be circumferential around the heart.A total of 900 cc of fluid was drained via pericardiocentesis, after which the patient was reported to be stable.The reporter indicated a belief that the pericardial effusion was caused by the abbott amplatzer amulet device.
Additional Manufacturer Narrative
An event of pericardial effusion after a month of amulet device implant was reported.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 available, it is difficult to determine with certainty the exact cause of the reported event, including whether the amulet¿s device contributed to the pericardial effusion.The reported hospitalization, and unexpected medical intervention was result of pericardiocentesis performed for effusion.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) 2026, a 25mm amplatzer amulet was implanted using a 14f amulet delivery system.No pericardial effusion was noted prior to the procedure.Transseptal access was obtained via an inferior anterior transseptal puncture, and heparin was administered during the procedure.The left atrial pressure at the time of the procedure was reported to be 10 mmhg.There was no reported difficulty with device implantation, and no multiple device manipulations were documented.During the procedure, a sheath exchange was performed in the left atrium, and a wire may have been placed in the left atrial appendage, possibly a versacross wire.On (b)(6) 2026, the patient presented with a delayed pericardial effusion, which was described as circumferential in nature.The effusion was not localized to a specific cardiac structure and was noted to be circumferential around the heart.A total of 900 cc of fluid was drained via pericardiocentesis, after which the patient was reported to be stable.The reporter indicated a belief that the pericardial effusion was caused by the abbott amplatzer amulet 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: 24651886
• Report Number: 2135147-2026-01786
• Device Sequence Number: 15921843
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300531(10)10914590
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10914590
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male