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

Model Number	9-ACP2-007-022
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	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning 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 22mm amplatzer amulet was implanted using a 14f amulet delivery system according to ifu.The patient was in atrial fibrillation at the time of the procedure, and no pericardial effusion was noted prior to the start of the procedure.A transseptal puncture was performed, described as central in the long axis and almost posterior in the short axis, and the guidewire was positioned in the upper pulmonary vein.Multiple manipulations were required due to difficult left atrial appendage anatomy.During the procedure, heparin (10,000 iu) was administered, and the activated clotting time was maintained above 250 ms.Toward the end of the procedure, a circumferential pericardial effusion was observed, circular in distribution, with the largest measured dimension of approximately 10 mm.Cardiac tamponade was concluded to be present by the physician(s).The pericardial effusion was managed with medication and pericardiocentesis, and protamine was administered after the procedure.Due to the pericardial effusion and difficulty related to manipulation within the left atrial appendage, the procedure was aborted, and no device was ultimately implanted.The physician did not determine whether an abbott device caused the pericardial effusion and considered procedural manipulation in the left atrial appendage as a possible contributing factor.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of pericardial effusion and cardiac tamponade was reported.Information from the field indicated that multiple manipulations were required due to difficult left atrial appendage anatomy.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.The reported unexpected medical intervention was a result of protamine medication was administered after the procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the 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: 24683812
• Report Number: 2135147-2026-01906
• Device Sequence Number: 18555025
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300731(10)10983991
• 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
• Device Explanted 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): 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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10983991
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Patient Sex: Unknown