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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cognitive Changes (2551); Pericardial Effusion (3271)
Date of Event	11/07/2025
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 31mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.Transseptal puncture was mid/superior and mid.The patient's activated clotting time (act) level was 331 seconds.The patient's left atrial pressure was 12mmhg.During the procedure the occluder was partially re-captured three times.The occluder was implanted slightly deeper than anticipated, however the device remained stable with no leaks.Post-procedure the patient complained of confusion during the night.The following morning a 1cm pericardial effusion was discovered in the left atrial appendage and left ventricle.The patient was held for an additional day for monitoring and then discharged with a pause of oral anti-coagulants for one week.No intervention was required.The user believed the occluder caused the pericardial effusion.
Event or Problem Description
It was reported on (b)(6) 2025 a 31mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.Transseptal puncture was mid/superior and mid.The patient's activated clotting time (act) level was 331 seconds.The patient's left atrial pressure was 12mmhg.During the procedure the occluder was partially re-captured three times.The occluder was implanted slightly deeper than anticipated, however the device remained stable with no leaks.Post-procedure the patient complained of confusion during the night.The following morning a 1cm pericardial effusion was discovered in the left atrial appendage and left ventricle.The patient was held for an additional day for monitoring and then discharged with a pause of oral anti-coagulants for one week.No intervention was required.The user believed the occluder caused the pericardial effusion.
Additional Manufacturer Narrative
An event of patient-device incompatibility with patient effects of cognitive change and 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, cognitive change, and pericardial effusion, could not be confirmed.Prolonged hospitalization was a result of case-specific circumstances.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: 23694635
• Report Number: 2135147-2025-07061
• Device Sequence Number: 10215954
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)271231(10)8831336
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/15/2025

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8831336
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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: Hospitalization
• Patient Sex: Unknown