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	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using a left atrial appendage (laa) closure procedure.The shape of the appendage was broccoli-shaped.The landing zone measurements were 18.4¿27.7 mm.On 135° tee, a small distal pectinate muscle was developed, and the morphology was relatively shallow.Intraoperatively, the left atrial pressure was 12 mmhg.Placement of a 35-mm watchman device was attempted; however, the device was not stable on the tug test after deployment and migrated into the left atrial appendage, resulting in an unstable position.The device was therefore changed to an amulet device.After disc deployment, the close sign was checked, and images were confirmed with color doppler imaging, a tension test, and contrast angiography.The amulet position became stable on the second deployment.The device compression was in a tire shape.There was no significant peri-device leak was observed, and the distance between the pulmonary artery and the left atrial appendage was considered acceptable at =3 mm.There was no pericardial effusion or other signs of complications were observed until the patient left the procedure room.Next morning, chest radiography showed no issues with device position.However, an echocardiographic examination in the afternoon confirmed device embolization into the left atrium.There was no blood flow obstruction occurred.A percutaneous device retrieval was performed and successfully completed on the same day.The physician believed cause of the device embolization was selection of a smaller-sized device.The patient was reported stable.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device embolization is likely related to device mis-sizing, however this could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as the device was removed via snare.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: 24470502
• Report Number: 2135147-2026-01217
• Device Sequence Number: 21243669
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)291231(10)10665879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/13/2026

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: 10665879
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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 Age: 89 YR
• Patient Sex: Male
• Patient Weight: 62 KG