MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-010-025
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Shock (2072)
Date of Event	06/30/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2026 a 25 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.The imaging modalities used during the procedure were echocardiography and angiography.The landing zone measurements were 19 mm at 0 degrees, 19 mm at 45 degrees, 20 mm at 90 degrees, and 20 mm at 135 degrees.During the procedure, fluid was given and the left atrial pressure was above 12 mmhg.Two partial recaptures were performed for repositioning.No leak was detected around the lobe, close criteria were met, and a tension test was performed.The device shape was roman helmet.The device was implanted.After the procedure, on the same day, echo imaging demonstrated the device embolized to the mitral valve.Cardiac surgery was performed to address the embolization.The device was removed from the body.However, during the cardiac surgery the patient went into shock and passed away.

• 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: 50038911
• Report Number: 2135147-2026-05139
• Device Sequence Number: 9853436
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)310131(10)11260054
• 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: 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
• Report Date (Section B): 07/27/2026

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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 11260054
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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; Death
• Patient Sex: Unknown