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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shock (2072)
Date of Event	01/01/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was implanted using a 14f amulet delivery system under tee guidance.Device sizing was instead determined on the day of the case using tee measurements.The landing zone measurements obtained via tee were 17, 16, 17, and 19 mm at 0, 45, 90, and 135 degrees, respectively, and based on the ifu sizing chart, a 22mm device was selected.During the procedure, the patient did not experience any rhythm changes.A non- abbott wire was placed in the left atrial appendage, and the patient¿s left atrial pressure measured 13 mmhg.The device required three partial recaptures/repositioning attempts before final deployment, and at the time of implant, the device exhibited tire/barrel compression.The patient was discharged on the same day.On (b)(6) 2026, the patient presented to the emergency department with shortness of breath and was found to be in multi-organ failure.The patient subsequently passed away.The cause of death was determined to be multi-organ failure, and the implanter classified the event as being related to the procedure and the patient¿s comorbidities.
Additional Manufacturer Narrative
Investigation is not yet complete.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 22mm amplatzer amulet was implanted using a 14f amulet delivery system under tee guidance.Device sizing was instead determined on the day of the case using tee measurements.The landing zone measurements obtained via tee were 17, 16, 17, and 19 mm at 0, 45, 90, and 135 degrees, respectively, and based on the ifu sizing chart, a 22mm device was selected.During the procedure, the patient did not experience any rhythm changes.A non-abbott wire was placed in the left atrial appendage, and the patient¿s left atrial pressure measured 13 mmhg.The device required three partial recaptures/repositioning attempts before final deployment, and at the time of implant, the device exhibited tire/barrel compression.The patient was discharged on the same day.On (b)(6) 2026, the patient presented to the emergency department with shortness of breath and was found to be in multi-organ failure.The patient subsequently passed away.The cause of death was determined to be multi-organ failure, and the implanter classified the event as being related to the procedure and the patient¿s comorbidities.
Additional Manufacturer Narrative
It was reported that the patient expired one day post amulet implant procedure.The device remained implanted and was not returned to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Requests were made for additional procedural details surrounding the case (e.G., operative notes, procedure imaging), however this information was not supplied by the site.Information field indicated that the cause of death was related to the procedure and patient¿s comorbidities such as shortness of breath.However, based on the limited information received the root cause of patient death could not be conclusively determined.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: 24192620
• Report Number: 2135147-2026-00441
• Device Sequence Number: 20800601
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)291231(10)10699271
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/17/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10699271
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Male