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	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 31mm amplatzer amulet was implanted using a 14f amplatzer torqvue delivery system.It was noted that the device embolized after being deployed while the patient was still hospitalized.The device was explanted on (b)(6) 2025, and the patient is currently home and stable with a new device in place.The landing zone measurements used to determine the device size were 22, 23, 25, and 27 at 0°, 45°, 90°, and 135° respectively.Device sizing was determined by using all available imaging and measurements, including computed tomography (ct) analysis, transesophageal echocardiography (tee), intracardiac echocardiography (ice), angiography (angio), and left atrial (la) pressure.Imaging modalities used during the procedure were transesophageal echocardiography (tee), intracardiac echocardiography (ice), and angiography (angio), and the embolization was identified via transthoracic echocardiography (tte).The device completely dislodged from the implant site and migrated to the left ventricle (lv).The implanter believes the cause of embolization is unknown but noted that upon deployment of the final device, the left atrial (la) pressure was 22 mmhg (compared to 13 mmhg during the previous implant).It became known that the device had embolized post-imaging the next day.The close criteria were satisfied.The patient did not experience a rhythm change during the procedure.A tension test was performed with disc optimization.The left atrial (la) pressure at the time of the procedure was 13 mmhg, and fluid was given with anesthesia but none specifically to boost la pressure.The device shape at implant was compressed with offset between the waist and distal end screw, taking the shape of the anatomy.There was no difficulty with implanting the device, as it was a single deployment.To address embolization, percutaneous retrieval was performed, and a new device was implanted.The retrieval was not considered an emergency procedure, as the patient remained continuously stable with no symptoms.
Additional Manufacturer Narrative
An event of device migrated to left ventricle was reported.Information from the field indicated that there was no difficulty with implanting the device, as it was a single deployment.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 incident could not be conclusively determined.The intervention was result of retrieval of migrated device.The patient was reported as stable with a new device in place.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: 23784596
• Report Number: 2135147-2025-07299
• Device Sequence Number: 10374612
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)290831(10)10501719
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: 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?: Yes
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 12/11/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male