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); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, 25mm amplatzer amulet was chosen for implanted using an 14f amplatzer torqvue delivery system.No pericardial effusion was noted prior to the procedure, and the transseptal puncture was performed in a posterior and inferior location.Heparin was administered during the procedure, with the activated clotting time reported to be greater than 300 seconds.Approximately two months after the procedure, the patient presented with symptoms of heart failure.Further evaluation identified a pericardial effusion localized to the left atrial appendage, with associated cardiac tamponade, which was subsequently managed with percutaneous drainage.The user indicated a belief that the pericardial effusion was caused by the anchors of the amulet device.Following this intervention, the patient recovered and was reported to have no ongoing consequences.
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.
Additional Manufacturer Narrative
An event of an implant related tissue damage, heart failure, 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 related tissue damage could not be determined.The reported pericardial effusion, cardiac tamponade, and heart failure were likely cascading effects from the event, however this cannot 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.
Event or Problem Description
It was reported that on (b)(6) 2026, 25mm amplatzer amulet was chosen for implanted using an 14f amplatzer torqvue delivery system.No pericardial effusion was noted prior to the procedure, and the transseptal puncture was performed in a posterior and inferior location.Heparin was administered during the procedure, with the activated clotting time reported to be greater than 300 seconds.Approximately two months after the procedure, the patient presented with symptoms of heart failure.Further evaluation identified a pericardial effusion localized to the left atrial appendage, with associated cardiac tamponade, which was subsequently managed with percutaneous drainage.The user indicated a belief that the pericardial effusion was caused by the anchors of the amulet device.Following this intervention, the patient recovered and was reported to have no ongoing consequences.

• 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: 24913156
• Report Number: 2135147-2026-02517
• Device Sequence Number: 9196047
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300131(10)10722157
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/01/2026

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: 10722157
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male