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	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 a 31 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.Intracardiac echocardiography (ice) imaging was used during the procedure.The landing zone measurements were 28 mm at 0 degrees, 26 mm at 45 degrees, 26.8 mm at 90 degrees, and 27 mm at 135 degrees.The left atrial pressure was above 12 mmhg.The lobe was not able to be properly seated due to the presence of pectinate muscles requiring two partial recaptures.No leak was detected.Close criteria were met and a tension test was performed.The device was implanted.The observed device shape was roman helmet.The following day, x-ray angiogram confirmed the device had embolized to the left atrium.The device was surgically removed via open heart surgery.The patient status was stable.The physician believed the presence of the pectinate muscles caused the device embolization.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50161942
• Report Number: 2135147-2026-05341
• Device Sequence Number: 12827719
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)291231(10)10697025
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/21/2026

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: 10697025
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown