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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 28mm amplatzer amulet was chosen for implant using a 14f amulet delivery sheath.During the procedure, following placement of the device, a gaseous embolism was observed.The patient was under general anesthesia.Heparin was administered after the transseptal puncture.The physician prepared and flushed the device until no bubbles were observed, and no air was noted in the device during preparation or the procedure.A continuous flush was attached to the ¿y¿ connected to the loader.After confirmation of adequate back bleeding, the sheath hub was maintained below the level of the patient¿s heart in accordance with ifu guidance, and the loader was immediately connected to the delivery sheath.After connection, the loader was not loosened, disconnected, or repositioned, and the hemostasis valve was not loosened at any time prior to or during device advancement.The device was then advanced into the delivery system.During device progression into the 14f amulet delivery sheath, air bubbles were first observed on imaging.Subsequently, echocardiographic imaging demonstrated air bubbles within the left ventricle.The gaseous embolism was assessed to be originating at the exit of the 14f amulet delivery sheath, rather than from the pre-attached delivery cable.No air bubbles were observed at any time in the loader tubing, y-connector, or near the hemostasis valve following final flushing.The patient exhibited st-segment elevation temporally associated with the air embolism, and atropine was administered.As a precautionary measure, the patient was placed in a hyperbaric chamber.Inspection of the delivery system did not identify any leaks, and there was no allegation of malfunction related to the abbott device or the procedural steps performed.In the physician¿s opinion, the most likely cause of the air embolism was the sheath design without a valve.Despite the event, the 28 mm amplatzer amulet device was successfully implanted.The patient fully recovered, experienced no further complications, and was discharged home.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned 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 ; 6517565400
• MDR Report Key: 24719730
• Report Number: 2135147-2026-01991
• Device Sequence Number: 5170337
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)300731(10)10988295
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/27/2026

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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 10988295
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male