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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/16/2025
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 chosen for implant using a 14famplatzer torqvue delivery sheath in a 79-year-old female patient.The procedure involved one deployment of the device.During the procedure, two transeptal punctures were performed due to loss of access in the left atrium.The device initially moved back proximally upon deployment but met close criteria and passed the tug test.Following deployment, the tee physician identified a pericardial effusion located on the posterior wall.The effusion measured approximately 6 mm and was noted to be circumferential.The effusion was monitored for 10 minutes and appeared stable without further enlargement.The echocardiography probe was subsequently removed, and the patient was scheduled to remain in the hospital overnight for observation.Additional information from the account is expected to be provided later.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was chosen for implant using a 14famplatzer torqvue delivery sheath in a 79-year-old female patient.There was trace of pericardial effusion noted prior to procedure.The procedure involved one deployment of the device and during the procedure, two transeptal punctures were performed in the inferior mid due to loss of access in the left atrium.The device initially moved back proximally upon deployment but met close criteria and passed the tug test.During the procedure, the patient had normal sinus rhythm and act levels were over 250, the left atrial pressure recorded as 14 and heparin was also administered during the procedure.Following deployment, the tee physician identified a pericardial effusion located on the posterior wall.The effusion measured approximately 6 mm and was noted to be circumferential and there was no cardiac tamponade present.The effusion was monitored for 10 minutes and appeared stable without further enlargement.Pericardiocentesis was performed to resolve the pericardial effusion.The physician and the team are unsure for the cause of pericardial effusion.The echocardiography probe was subsequently removed, and the patient was scheduled to remain in the hospital overnight for observation.
Additional Manufacturer Narrative
An event with patient effects of pericardial effusion was noted.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 of the reported pericardial effusion could not be confirmed.An unexpected medical intervention and hospitalization were a result of case-specific circumstances, as a pericardiocentesis was performed and the patient remained in the hospital for observation.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: 24035675
• Report Number: 2135147-2026-00227
• Device Sequence Number: 18406590
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)290930(10)10559301
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• 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: 10559301
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female