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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
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, an 18mm amplatzer amulet device was selected for implantusing an unknown delivery system.Within 24 hours post-procedure, the patient developed a pericardial effusion, and approximately 200 ml of fluid was drained.The patient was stabilized, remained hospitalized for an additional night, and was subsequently discharged on (b)(6) 2025.
Additional Manufacturer Narrative
An event for patient effects of pericardial effusion was reported.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 defined manufacturing specifications.Based on the information received, the cause of the reported pericardial effusion could not be determined.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, an 18mm amplatzer amulet device was selected for implantusing an unknown delivery system.Within 24 hours post-procedure, the patient developed a pericardial effusion, and approximately 200 ml of fluid was drained.The patient was stabilized, remained hospitalized for an additional night, and was subsequently discharged on (b)(6) 2025.
Additional Manufacturer Narrative
An event for patient effects of pericardial effusion was reported.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 defined manufacturing specifications.Based on the information received, the cause of the reported pericardial effusion could not be determined.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, an 18mm amplatzer amulet device was implanted using a 12f amplatzer torqvue delivery system.The transseptal puncture was performed at the mid/mid septum.During the procedure, the device was never completely retracted into the delivery system, and there was no difficulty implanting the device.Heparin was administered during the procedure, and the patient was in sinus rhythm.Protamine was given following the procedure.A wire was not placed in the left atrial appendage.Within 24 hours post-procedure, the patient developed a pericardial effusion, and approximately 200 ml of fluid was drained.The effusion was circumferential and was noted around the left ventricle.The pericardial effusion led to cardiac tamponade.The effusion was resolved via pericardiocentesis.At the time the effusion was identified, the patient was taking dual antiplatelet therapy (dapt) and had been on eliquis prior to the procedure.The patient was stabilized, remained hospitalized for an additional night, and was subsequently discharged on (b)(6) 2025.

• 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: 23381162
• Report Number: 2135147-2025-06094
• Device Sequence Number: 20049429
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)280131(10)8900583
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 8900583
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 03/25/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/25/2025; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Unknown