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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/18/2025
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 an unknown date, an unknown amplatzer amulet was chosen for implant using an unknown delivery system.Following the procedure, the physician reported observing two late effusions.The patients were reported to be in stable condition.The physician indicated that the effusions might be related to the patients being placed on eliquis post-procedure, which is a practice he typically follows for ablation patients.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.A returned device assessment could not be performed as the device was not returned for analysis.Procedural imaging was limited, and the device appears to have the disc up on the pulmonary vein ridge.Based on the imaging provided, a conclusion for why the pericardial effusion occurred is unknown.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 could not be determined.It is possible that procedural circumstances contributed to the event, however this cannot be determined.An unexpected medical intervention was a result of case specific circumstances, as pericardiocentesis was performed to treat pericardial effusion.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: health effect- impact code: 4614.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was chosen for implant using a 14f amulet steerable delivery system.The sizing of the laao anatomy was determined to be a 16mm landing zone and a 24mm ostium, and the 20mm amplatzer amulet device was subsequently implanted without complications.On an unknown date following the procedure, it was reported that the patient returned with a pericardial effusion.The pericardial effusion was managed with pericardiocentesis, after which the patient was discharged without complications.It was further reported that the patient was on eliquis at the time of discharge and remained on eliquis at the time the pericardial effusion occurred.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24037903
• Report Number: 2135147-2026-00241
• Device Sequence Number: 18762489
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300228(10)10783839
• 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: 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): 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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10783839
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2025
• 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; Other; Hospitalization
• Patient Sex: Unknown