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

Model Number	9-ACP2-010-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that (b)(6) 2026, a 25mm amplatzer amulet was chosen for implant using a 12f amulet delivery system.At baseline, no pericardial effusion was present prior to the start of the procedure.The patient was in sinus rhythm, and heparin was administered during the procedure at a total dose of 15,000iu, achieving an activated clotting time (act) greater than 300 seconds, with no protamine or reversal agent administered.The transseptal puncture was performed via an inferior posterior approach, and the guidewire was positioned in the upper pulmonary vein without multiple wire or delivery sheath exchanges.During advancement of the delivery system, difficulty was encountered in bringing the delivery sheath into the left atrial appendage, requiring manipulation.During the left atrial appendage implantation attempt, the patient developed a pericardial effusion.The effusion was circumferential, localized predominantly around the right ventricle, with a maximum measured dimension of 0.4mm.There was no evidence of cardiac tamponade, and the effusion was not believed to be caused by the abbott device.As a result of the effusion, the procedure was stopped.The pericardial effusion resolved spontaneously without the need for medication, pericardiocentesis, or surgical intervention.At the time the effusion was detected, the patient was receiving aspirin, with no anticoagulant or antiplatelet therapy reported prior to the procedure.The patient was subsequently transferred in stable condition to the hospital ward.
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.
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.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.A serious injury/illness/impairment was a result of case specific circumstances, as there was no intervention to treat the pericardial effusion.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: 24737451
• Report Number: 2135147-2026-02047
• Device Sequence Number: 18452256
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300831(10)11063474
• 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): 04/10/2026

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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 11063474
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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
• Patient Sex: Male