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	Movement Disorder (4412)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event for patient effect of movement disorder 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 specifications.There were no complaints associated with any other devices from the lot.The reported prolonged hospitalization is likely a causing effect of the reported movement disorder.Based on the information received, the cause of the reported movement disorder could not be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(4) - catalyst ide study, patient site id: (b)(6).It was reported that on (b)(6)2024, a 18mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 12f amplatzer amulet delivery sheath.There was 1mm pericardial effusion was present prior to introduction of the delivery system.The laa depth was 24mm.During procedure, the atrial rhythm was atrial fibrillation (af), 500ml volume of fluids given and heparin was administrated.The amulet was successfully implanted.On (b)(6) 2025, the patient presented with dysarthria and weakness of the hand.The patient required prolonged hospitalization.
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.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23171526
• Report Number: 2135147-2025-05501
• Device Sequence Number: 13171589
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)280731(10)9187683
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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 Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 9187683
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 120 KG