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

Model Number	9-ACP2-010-028
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amplatzer amulet was chosen for implant using an unknown delivery system.During the procedure, when the physician unsheathed the device to the ball position, a small clot was observed on the ball-shaped portion of the amulet device.The physician was advised not to proceed with the deployment steps due to the presence of the clot and was instructed to carefully recapture the device.The procedure was subsequently aborted based on these findings and the patient¿s complex anatomy.No amulet device was implanted.
Additional Manufacturer Narrative
A patient device interaction problem and thrombus 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 patient device interaction problem and thrombus could not be determined.It is possible that procedural circumstances (device positioning) and/or anticoagulant therapy contributed to the even, however this cannot be determined.The reported patient effect of illness was cascading effect of thrombus.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) 2026, a 28mm amplatzer amulet was chosen for implant using an 14f amulet delivery system.The patient was prescribed eliquis, had a reported inr of 1.3 on the day of the procedure.Following venous access and imaging setup, tee imaging was used to guide the case.Heparin was administered intra-procedurally, with a total of 15,000 units given, and the patient¿s activated clotting time (act) was 333.During the procedure, when the physician unsheathed the device to the ball position, a small clot was observed on the ball-shaped portion of the amulet device.The clot was described as very small, appearing bright on the tee imaging screen, and located at the tip of the ball near the distal end screw.Due to the presence of this thrombus, the physician was advised not to proceed with deployment and was instructed to carefully recapture the device.Considering the observed thrombus and the patient¿s complex anatomy the physician was advised not to proceed with the deployment steps due to the presence of the clot and was instructed to carefully recapture the device.The procedure was subsequently aborted based on these findings and the patient¿s complex anatomy.No amulet device was implanted.

• 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: 24335035
• Report Number: 2135147-2026-00883
• Device Sequence Number: 15888912
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)300731(10)10996230
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/17/2026

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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 10996230
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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 Age: 73 YR
• Patient Sex: Male