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

Model Number	9-ACP2-007-020
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pericardial Effusion (3271)
Date of Event	02/11/2026
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) 2026, a 73-year-old male patient with paroxysmal atrial fibrillation underwent a concomitant left atrial closure and pulmonary vein isolation procedure, during which a 20mm amplatzer amulet device was implanted using a 12f amulet delivery sheath.Following completion of the procedure, the patient later reported thoracic pain.A tte subsequently identified a pericardial effusion, which was monitored closely and measured up to 8mm.No drainage was required, and the patient remained hemodynamically stable throughout the observation period.The patient ultimately recovered well and was discharged in good condition.
Event or Problem Description
It was reported that on (b)(6) 2026, a 73-year-old male patient with paroxysmal atrial fibrillation underwent a concomitant left atrial closure and pulmonary vein isolation procedure, during which a 20 mm amplatzer amulet device was implanted using a 12f amulet delivery sheath.The patient was in sinus rhythm at the time of the procedure and had been receiving oral anticoagulation therapy prior to the intervention, with the last dose taken the evening before the procedure.A loading dose of acetylsalicylic acid (asa) was administered on the morning of the procedure, and oral anticoagulation was discontinued the evening of the procedure.A transseptal puncture was performed in an inferior-mid location as part of the combined procedure.Multiple wire and delivery sheath exchanges were required, with wire positioning in the upper pulmonary vein, due to a small left atrial appendage with complex anatomy.During the procedure, heparin was administered at a total dose of 18,000 iu, with activated clotting time values ranging between 298 and 357 seconds, and the left atrial pressure was recorded between 10 and 14 mmhg.Following completion of the procedure, the patient later reported thoracic pain.A transthoracic echocardiogram identified a circumferential pericardial effusion, which was further characterized on ct scan as anterior and inferior, measuring up to 8 mm, and subsequently measured up to 9 mm on transesophageal echocardiography.The pericardial effusion was managed conservatively with medication, and no pericardial drainage, surgical intervention, or cardiac tamponade was identified.The patient remained hemodynamically stable throughout the monitoring period.It was noted that the user considered a possible association between the abbott amulet 20 mm device and the pericardial effusion, in the context of a combined procedure involving pulsed field ablation and challenging appendage anatomy.The patient ultimately recovered well, the effusion did not progress, and the patient was discharged in good condition.
Additional Manufacturer Narrative
An event of patient-device incompatibility was reported with pericardial effusion.A returned device assessment could not be performed as the device remains implanted.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 patient-device incompatibility could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as a medication was provided.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4614.Medical device problem code: 2993.

• 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: 24612641
• Report Number: 2135147-2026-01678
• Device Sequence Number: 15993581
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)271130(10)8799139
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/08/2026

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: 8799139
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2022
• 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: 73 YR
• Patient Sex: Male