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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 an 18mm amplatzer amulet left atrial appendage occluder was selected for implant to treat a left atrial appendage (laa).Device sizing was determined based on left atrial pressure and echocardiogram (echo) and angiography (angio).Echo and angio were used during the procedure.The patient's landing zone on the short axis was 11mm on the short axis and 15mm on the long axis.The patient's left atrial pressure was 11 mmhg.During the procedure the occluder was partially re-captured twice.A tension test was performed.Close criteria were met.The occluder was implanted.On (b)(6) 2025 during a follow-up transesophageal echocardiogram (tee) it was observed that the occluder was partially anchored on the ventricle.The patient was hospitalized and transferred to a different clinic for cardiac surgery.The patient status at this point was stable with no blood pressure fluctuations.On (b)(6) 2025, at the beginning of the cardiac surgery it was noted that the occluder was actually in the abdominal aorta.The patient was awakened and admitted to the cardiac intensive care unit (cicu) while awaiting percutaneous retrieval in the hemodynamics lab.At the time of transferring to the hemodynamics room, the patient lost consciousness.The patient was intubated and taken for a computed tomography (ct) scan.The scan showed no abnormalities and the percutaneous retrieval proceeded.The occluder was successfully removed.The patient remained in the cicu for monitoring.
Additional Manufacturer Narrative
An event of device migration approximately three months after the device implant was reported.During a follow up-tee, the decision was made to hospitalize the patient for cardiac surgery.At the beginning of the cardiac surgery procedure, the patient lost consciousness.The device was surgically explanted and a new device was implanted successfully.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 specifications.There were no complaints associated with any other devices from the lot.It is possible that procedural condition and challenging anatomy could have contributed to this event.However, this cannot be confirmed.The reported unexpected medical intervention of removing the device was a result of case-specific circumstances as the device was scheduled to be snared.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 22299716
• Report Number: 2135147-2025-03352
• Device Sequence Number: 9739392
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)280229(10)8936944
• 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: 2025
• Device Explanted Year: 2025
• 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): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 8936944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2023
• 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 Age: 78 YR
• Patient Sex: Male