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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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 28mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath.After the implant, it was noted that the device migrated in the patient's body.The patient was then transferred to the surgery département of another hospital.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Event or Problem Description
It was repoprted that on (b)(6) 2025, a 28mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath.Pre-implant landing zone measurements were 20/21 mm at 45° and 22/23 mm at 130°, and device sizing was determined with a sizing card.Transesophageal ultrasound was used as the imaging modality during the procedure.After deployment, the device exhibited a barrel shape, a tension test was performed twice, the close criteria were satisfied, there was no rhythm change, no leak was detected around the lobe, no fluid was administered, and therefore left atrial pressure was not re-measured after fluids.Subsequently, it was noted that the device migrated; migration was identified on transesophageal ultrasound, the device was completely dislodged from the implant site, and the implanter did not know the cause of the embolization/migration.Surgical intervention was performed to address the migration, and the patient was transferred to the surgery department of another hospital.The patient remained hemodynamically stable throughout the procedure, with no clinically significant procedural delay and no adverse patient effects.
Additional Manufacturer Narrative
An event of device embolization was reported.The occluder device was returned to abbott and the device met dimensional specification when analyzed.Two transesophageal echocardiography (tee) images of the implanted device were provided and reviewed.The images showed the device still positioned within the appendage prior to migration.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 and cine review, the cause of the reported device embolization could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstance as the migrated 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.

• 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: 24075012
• Report Number: 2135147-2026-00308
• Device Sequence Number: 9113545
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)291231(10)10690098
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 10690098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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 Sex: Unknown