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 Codes	Angina (1710); Dyspnea (1816); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/01/2025
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, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using an unknown delivery system.The anatomy was complex, and initially, a 20mm amplatzer amulet device was chosen based on the measurements, which ranged between 15 and 17mm for the landing zone.During procedure, heparin was administered.However, the position and conformation of the device were not adequate.They even attempted to reposition it twice, but it remained unsuitable for release (outside the close criteria).The 20mm amulet removed from the patient prior to release from the delivery cable.A new 18mm amplatzer amulet left atrial appendage occluder was then opened, and it met the release criteria.The device was successfully deployed using the same delivery system.After the procedure, the patient was extubated and presented with shortness of breath and chest pain.An echocardiogram was performed, revealing a 5mm circumferential pericardial effusion.A cardiac tamponade was also present.The patient was kept under observation.As there was no progression, protamine was administered, and the effusion decreased.The following day, the patient remained stable.A repeat echocardiogram showed no progression of the effusion, and yesterday afternoon, they received information that the patient was doing well, with no effusion, and was discharged.
Additional Manufacturer Narrative
An event for patient effects of pericardial effusion and cardiac tamponade was reported.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 defined manufacturing specifications.Based on the information received and per event details, the cause of the reported pericardial effusion and cardiac tamponade could not be determined.There were no complaints associated with any other devices from the lot.Per the information available abbott cannot further speculate on why the reported occurred.The reported unexpected medical intervention was a result of case-specific circumstances, as medication was provided.

• 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: 23154606
• Report Number: 2135147-2025-05441
• Device Sequence Number: 17447544
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)251130(10)7768997
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/14/2025

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 Expiration Date: 11/30/2025
• Device Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 7768997
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2020
• 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: 85 YR
• Patient Sex: Female