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	Respiratory Tract Infection (2420); Pericardial Effusion (3271)
Date of Event	09/23/2025
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 on (b)(6) 2025 a 20mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath.The patient had a pre-existing atrial fibrillation and lung infection.Transseptal puncture was inferior and mid.The patient's activated clotting time (act) level was approximately 250 seconds.Heparin was administered.During the procedure the occluder was partially re-captured twice.Upon closing the left atrial appendage, the patient presented with an 8mm moderate pericardial effusion.The patient had prolonged hospitalization for monitoring.Approximately a week from the procedure the patient developed a pulmonary infection.The infection was treated.The patient status was stable.The user believed the pericardial effusion was due to the patient's pre-existing lung condition.
Additional Manufacturer Narrative
An event of pericardial effusion and respiratory tract infection was reported.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 pericardial effusion and respiratory tract infection could not be confirmed.An unexpected medical intervention and a prolonged hospitalization are results of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 20mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath.The patient had a pre-existing atrial fibrillation and lung infection.Transseptal puncture was inferior and mid.The patient's activated clotting time (act) level was approximately 250 seconds.Heparin was administered.During the procedure the occluder was partially re-captured twice.Upon closing the left atrial appendage, the patient presented with an 8mm moderate pericardial effusion.The patient had prolonged hospitalization for monitoring.Approximately a week from the procedure the patient developed a pulmonary infection.The infection was treated.The patient status was stable.The user believed the pericardial effusion was due to the patient's pre-existing lung condition.

• 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: 23659259
• Report Number: 2135147-2025-06938
• Device Sequence Number: 15959309
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300228(10)10776005
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 10776005
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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; Hospitalization
• Patient Sex: Unknown