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

Model Number	9-ACP2-010-034
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 34 mm amplatzer amulet was implanted using a 14f amulet delivery sheath.The transseptal puncture was performed in an inferior and posterior location.A few hours later, pericardial effusion was noted, and pericardiocentesis was performed.The effusion was circumferential with the largest dimension measuring 4 cm.Cardiac tamponade was concluded to be present.During the procedure, the patient¿s activated clotting time (act) was 320, and 5000 ui of heparin was administered.There was no difficulty implanting the device, and no multiple manipulations were reported.The patient was taking clopidogrel both prior to and at the time the effusion was detected.The patient was in atrial fibrillation during the procedure.There were no multiple wire or delivery sheath exchanges, and the wire position was in the left upper pulmonary vein.The left atrial pressure at the time of the procedure was 11 mmhg.The user believes an abbott device caused the pericardial effusion.The patient is reported to be stable.
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 34 mm amplatzer amulet was implanted using a 14f amulet delivery sheath.The transseptal puncture was performed in an inferior and posterior location.A few hours later, pericardial effusion was noted, and pericardiocentesis was performed.The effusion was circumferential with the largest dimension measuring 4 cm.Cardiac tamponade was concluded to be present.During the procedure, the patient¿s activated clotting time (act) was 320, and 5000 ui of heparin was administered.There was no difficulty implanting the device, and no multiple manipulations were reported.The patient was taking clopidogrel both prior to and at the time the effusion was detected.The patient was in atrial fibrillation during the procedure.There were no multiple wire or delivery sheath exchanges, and the wire position was in the left upper pulmonary vein.The left atrial pressure at the time of the procedure was 11 mmhg.The user believes an abbott device caused the pericardial effusion.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of patient-device incompatibility, pericardial effusion, and cardiac tamponade was reported.There are multiple risk factors for pericardial effusion after a left atrial appendage closure procedure, including anticoagulation status of the patient, maneuvering of the guidewire or sheaths within the heart, the trans-septal puncture, or the stabilizing wires on the amulet puncturing the laa.During the procedure, the patient¿s activated clotting time (act) was 320, and 5000 ui of heparin was administered.There was no difficulty implanting the device, and no multiple manipulations were reported.There were no multiple wire or delivery sheath exchanges, and the wire position was in the left upper pulmonary vein.A returned device assessment could not be performed as the device 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 information received, the cause of the reported patient-device incompatibility, pericardial effusion, and cardiac tamponade could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances as the pericardiocentesis was performed.

• 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: 23729568
• Report Number: 2135147-2025-07196
• Device Sequence Number: 10631444
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)270531(10)8543030
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/13/2026

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-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 8543030
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14F AMULET DELIVERY SHEATH.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown