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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet was chosen for implant.After implantation, it was noted that the device had embolized post procedure.Landing zone measurements obtained via ice were aortic: 24mm, mitral: 28mm, and supramitral: 24mm, and sizing was determined using the maximum ice landing zone measurement plus 3mm.Intracardiac echo was used during the procedure, and ct imaging identified the migration.The device completely dislodged from the implant site and traveled to the left atrium.Close criteria were satisfied, and the patient remained in sinus rhythm after af ablation throughout the implant.A tension test was performed, and left atrial pressure was above 12 mmhg.At implant, the device shape was roman helmet, and no leak was detected around the lobe.The patient experienced no clinical signs or symptoms, and there was no difficulty with implanting the device, such as multiple recaptures or repositioning.Surgery was planned to address embolization, but completion is unclear due to complexity and a plan for coronary artery bypass grafting.The embolized device did not cause obstruction or blockage of blood flow, and retrieval was not considered an emergency procedure to prevent permanent impairment or death.
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.
Additional Manufacturer Narrative
An event of device embolization into the left ventricle was reported.A cine review was completed, and concluded, 2 images were received.One shows before the final release of the device and the other is a post-implant ct that demonstrates embolization.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 defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported device embolization could not be determined.A surgical intervention was a result of case-specific circumstances, as the device was removed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet was chosen for implant.After implantation, it was noted that the device had embolized post procedure.Landing zone measurements obtained via ice were aortic: 24mm, mitral: 28mm, and supramitral: 24mm, and sizing was determined using the maximum ice landing zone measurement plus 3mm.Intracardiac echo was used during the procedure, and ct imaging identified the migration.The device completely dislodged from the implant site and traveled to the left atrium.Close criteria were satisfied, and the patient remained in sinus rhythm after af ablation throughout the implant.A tension test was performed, and left atrial pressure was above 12 mmhg.At implant, the device shape was roman helmet, and no leak was detected around the lobe.The patient experienced no clinical signs or symptoms, and there was no difficulty with implanting the device, such as multiple recaptures or repositioning.Surgery was planned to address embolization, but completion is unclear due to complexity and a plan for coronary artery bypass grafting.The embolized device did not cause obstruction or blockage of blood flow, and retrieval was not considered an emergency procedure to prevent permanent impairment or death.It was further clarified that the amulet was removed.

• 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: 24122514
• Report Number: 2135147-2026-00379
• Device Sequence Number: 5987357
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)290831(10)10501719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/19/2026

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 10501719
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male