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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, an unknown amplatzer was implanted using an unknown delivery system.On (b)(6) 2026, a doctor reported the presence of device-related thrombus (drt) in a patient with an amulet device, identified during a recent toe follow-up examination.The toe reportedly showed significant spontaneous ¿smoke¿.The patient was noted to be on the thrombin inhibitor dabigatran.The initial indication for left atrial appendage closure was hematuria.No additional information available.
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.
Additional Manufacturer Narrative
An event of a patient-device interaction problem of a thrombus was reported.A returned device assessment could not be performed as the device remains implanted.A cine review was completed, stating: one transesophageal echocardiogram image was provided from the follow-up study.The image showed a device-related thrombus attached to the left atrial surface of the amulet disc.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 interaction problem of a thrombus could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as medication was administered.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 that on (b)(6) 2025, an 28mm amplatzer amulet was implanted using an unknown delivery system.On (b)(6) 2026, a doctor reported the presence of device-related thrombus (drt) in a patient with an amulet device, identified during a recent toe follow-up examination.The toe reportedly showed significant spontaneous ¿smoke¿.No threads were observed, and the thrombus was described as a sessile, non-mobile thrombus located on the atrial side of the disc.The patient was reported to be on dabigatran 110 mg twice daily with good compliance, and during the procedure the activated clotting time (act) was greater than 300 seconds with heparin administered.The patient was noted to have significant spontaneous echo contrast in the left atrium, but no hypercoagulable disorder, and was not receiving any additional medications that could contribute to thrombus formation.The thrombus was detected using transoesophageal echocardiography (toe).The initial indication for left atrial appendage closure was hematuria.No additional information was available.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24405581
• Report Number: 2135147-2026-01075
• Device Sequence Number: 15917388
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)290930(10)10557593
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 10557593
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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
• Patient Sex: Male