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

Model Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Atrial Flutter (1730); Nausea (1970)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning 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 34mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 14f delivery system.The landing zone measurements were area 585.3 mm² and perimeter 86.7 mm.The sizing of the device was determined by feops heartguide with transesophageal echocardiography (toe/tee).During procedure, the left atrial pressure was above 12mmhg and approximately 1 liter of fluid was given.The device was positioned correctly in laa, all close sign observed, tug test performed adequately and the amulet detached without any issue.The device compression was in a roman helmet shape.Six hours after procedure, the patient experienced nausea and a fluttering in his chest, tee confirmed the device was embolized to the mitral valve and requiring an immediate surgical intervention.The patient was reported stable.
Additional Manufacturer Narrative
An event of device embolization into mitral valve, nausea, atrial flutter, 6hours post amulet implant 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.Based on the information received, the cause of the reported embolization is possibly related to anatomical factor (largeness of the laa ).However, the exact cause could not be conclusively determined.The surgical intervention is a case-specific circumstance as device was surgically removed.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 22977159
• Report Number: 2135147-2025-04991
• Device Sequence Number: 9540724
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280531(10)9097586
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 9097586
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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
• Patient Age: 87 YR
• Patient Sex: Male