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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet was implanted.On (b)(6) 2025, a leak was observed on the 31mm amplatzer amulet occluder by the coumandin ridge.The leak was identified using computed tomography (ct) scan.The measured size of the leak was approximately 10mm.No interventions were performed to address the leak and there was no additional device placement, surgical correction, or medication adjustment.The patient remains on dual antiplatelet therapy (dapt).The physician opted to monitor the patient without further treatment, and ongoing observation is currently in place.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 that on (b)(6) 2025, a 31mm amplatzer amulet was implanted.On (b)(6) 2025, a leak was observed on the 31mm amplatzer amulet occluder by the coumandin ridge.The leak was identified using computed tomography (ct) scan.The measured size of the leak was approximately 10mm.No interventions were performed to address the leak and there was no additional device placement, surgical correction, or medication adjustment.The patient remains on dual antiplatelet therapy (dapt).The physician opted to monitor the patient without further treatment, and ongoing observation is currently in place.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a residual shunt 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 residual shunt could not be confirmed.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: 23651130
• Report Number: 2135147-2025-06926
• Device Sequence Number: 21306328
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)280229(10)8930788
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8930788
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Male