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 Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/12/2025
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 (b)(6) 2025, a 20mm amplatzer amulet was implanted using a 14f amplatzer torqvue delivery system.One hour post procedure, the patient experienced pericardial effusion and pericardiocentesis was performed.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information provided.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet was implanted using a 14f amplatzer torqvue delivery system.The transseptal puncture location was inferior anterior.During the procedure, the patient¿s activated clotting time (act) was 258, and heparin was administered.Protamine was given, but not immediately after the procedure; there was a delay.The patient was in normal sinus rhythm (nsr) at the time of the procedure.There were multiple wire or delivery sheath exchanges, and the wire position was in the upper or lower pulmonary vein.The left atrial pressure at the time of the procedure was 17 mmhg.A wire was placed in the left atrial appendage.There was no difficulty implanting the device, such as multiple manipulations.One hour post-procedure, the patient experienced pericardial effusion and pericardiocentesis was performed.The user does not believe the abbott device caused the pericardial effusion; they believe it was due to the transseptal puncture.The physician(s) concluded that cardiac tamponade was present.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of pericardial effusion and cardiac tamponade one-hour post procedure was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information from field, it was believed that pericardial effusion was due to the transseptal puncture.However, the exact cause of the reported patient effect could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The unexpected medical intervention was result of pericardiocentesis was performed due to pericardial effusion.There were no complaints associated with any other devices from the lot.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: 23729502
• Report Number: 2135147-2025-07194
• Device Sequence Number: 18782106
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300331(10)10826906
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/27/2026

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: 10826906
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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 Age: 85 YR
• Patient Sex: Female