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	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amplatzer amulet was chosen for implant using an 14f amulet delivery sheath.No pericardial effusion was noted prior to the procedure.Following an inferior/posterior transseptal puncture, the team exchanged the initial catheter for the delivery sheath, after which the 28 mm amulet device was introduced.During the procedure, the patient was in sinus rhythm, and anticoagulation was maintained with 8000 iu of heparin, resulting in an activated clotting time (act) of 270 seconds.Advancement of the sheath into the laa presented some difficulty, and multiple manipulations were required because it was not easy to reach the laa with the device.At one point, the wire briefly lost its position in the pulmonary vein and entered the laa.However, the physician was ultimately able to access the laa, and the device was deployed without the need for recapture.Subsequently, a circumferential pericardial effusion at the right ventricle, measuring 1 cm at its largest dimension, was observed.This evolved into a clinical situation in which cardiac tamponade was identified by the physicians.Pericardial puncture was performed for management.The user does not believe the abbott device caused the pericardial effusion.After completion of the intervention, protamine was administered as a reversal agent.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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.
Event or Problem Description
N/a.

• 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: 24537182
• Report Number: 2135147-2026-01449
• Device Sequence Number: 13362660
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)291231(10)10665878
• 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): 03/31/2026

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: 10665878
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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 Sex: Male