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

Model Number	9-ACP2-007-022
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 22 mm amplatzer amulet was implanted using a 14f amulet delivery sheath.On (b)(6) 2025, 24 hours after the implant it was observed that the a moderate pericardial effusion was present requiring a pericardial window.No additional information provided.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was implanted using a 14f amulet delivery sheath.The transseptal puncture was performed at an inferior/mid-anterior location.On (b)(6) 2025, 24 hours after the implant, it was observed that a moderate pericardial effusion was present requiring a pericardial window.No pericardial effusion was noted prior to the procedure.The effusion was located centrally, measured 0.8 cm at its largest dimension, and was circumferential.The physician did not conclude that cardiac tamponade was present.The user believes the amulet device caused the pericardial effusion.During the procedure, the patient¿s activated clotting time (act) was 233, and an additional 7000 units of heparin were administered.There was one partial recapture and one full recapture of the device.The patient was not taking anticoagulant or antiplatelet medication at the time of detection or prior to the procedure.The patient was in sinus bradycardia during the procedure.No protamine or reversal agent was administered during or after the procedure.There were no multiple wire or delivery sheath exchanges, and wire position was not in the upper or lower pulmonary vein.The left atrial pressure at the time of the procedure was 13 mmhg.A versacross wire was placed in the left atrial appendage.The procedure was completed using a 25mm amplatzer amulet.
Additional Manufacturer Narrative
It was reported that pericardial effusion was observed, 24 hrs after amulet device implant.Information from field indicated that the amulet was implanted with no reported implant complications.Abbott requested for procedure imaging to review, this was not provided by the site.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the limited information received, the cause of the reported pericardial effusion could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the patient was treated with cardiac surgery.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: medical device problem code: 2993.

• 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: 23888482
• Report Number: 2135147-2025-07668
• Device Sequence Number: 4771611
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300630(10)10952502
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10952502
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female