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

Model Number	9-ACP2-010-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of thrombus formation was reported.A returned device assessment could not be performed, as the device remains implanted.Information from the field indicated that during the procedure, while the device was being deployed, the team observed a small thrombus on the delivery cable.The physician did not indicate any relationship between the thrombus and the amulet device.The thrombus was described as having the appearance of small threads.A review of the device history record confirmed that all manufacturing and inspection steps were completed and that the product met all defined specifications.No other complaints were reported for devices from this lot.Based on the available information, the cause of the reported thrombus cannot be determined.It is possible that patient comorbidities contributed to the event; however, this cannot be confirmed.The reported patient effect of illness appears to be a cascading effect resulting from the thrombus.There is no indication of any product quality issue related to device labeling, design, or manufacturing.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was chosen for implant using a 12f amulet delivery sheath.During the procedure, while deployment, the team observed a small thrombus formation at the delivery cable.The physician did not indicate any relationship between the thrombus and the amulet device.The thrombus was described as small threads in appearance.The sheath had not been in the patient for a significant period of time.During the procedure, the patient¿s activated clotting time (act) levels were 361 and 401, and heparin was administered.The thrombus was detected using tee imaging.The delivery sheath was not reused with multiple amulet occluders, and the amulet occluder was never fully resheathed and continued for use during the procedure.

• 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: 24621581
• Report Number: 2135147-2026-01715
• Device Sequence Number: 21229037
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300331(10)10832789
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• 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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 10832789
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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 Sex: Unknown