MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-007-016
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported on (b)(6) 2026 a 16 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath for a left atrial appendage (laa) closure.Prior to procedure, the patient was taking clopidogrel.The imaging modality used was transesophageal echocardiogram (tee).The landing zone measurements were: 0 degrees, 13.9 mm, 45 degrees, 14.4 mm, 90 degrees, 13.1 mm, and 135 degrees, 14.3.The laa was windsock shaped.The left atrial pressure was above 12 mmhg.The activating clotting time was 320 seconds and heparin was given.During the procedure the patient's heart rhythm was normal sinus rhythm.The device was positioned resting on the pulmonary vein ridge.No leak was detected around the lobe.Close criteria were satisfied and a tension test was performed.The device was implanted with a tire shape noted.The patient continued clopidogrel after the procedure.At the 45-day post op follow up, tee confirmed that the disc had shifted from the pulmonary vein ridge and appeared to be lodged in a depression on the anterior side at 135 degrees.Thrombus was confirmed at the position where the disc was lodged.Because the disc had dropped to this position, the lobe was not maintained.After confirmation of thrombus, clopidogrel was switched to lixiana (endoxanan).The physician suspected that the thrombus formed because the disc became lodged in a depression on the pulmonary vein ridge.However, this was not confirmed.No patient-related factors predisposing to thrombosis were identified.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2026 a 16 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amulet delivery sheath for a left atrial appendage (laa) closure.Prior to procedure, the patient was taking clopidogrel.The imaging modality used was transesophageal echocardiogram (tee).The landing zone measurements were: 0 degrees, 13.9 mm, 45 degrees, 14.4 mm, 90 degrees, 13.1 mm, and 135 degrees, 14.3.The laa was windsock shaped.The left atrial pressure was above 12 mmhg.The activating clotting time was 320 seconds and heparin was given.During the procedure the patient's heart rhythm was normal sinus rhythm.The device was positioned resting on the pulmonary vein ridge.No leak was detected around the lobe.Close criteria were satisfied and a tension test was performed.The device was implanted with a tire shape noted.The patient continued clopidogrel after the procedure.At the 45-day post op follow up, tee confirmed that the disc had shifted from the pulmonary vein ridge and appeared to be lodged in a depression on the anterior side at 135 degrees.Thrombus was confirmed at the position where the disc was lodged.Because the disc had dropped to this position, the lobe was not maintained.After confirmation of thrombus, clopidogrel was switched to lixiana (endoxanan).The physician suspected that the thrombus formed because the disc became lodged in a depression on the pulmonary vein ridge.However, this was not confirmed.No patient-related factors predisposing to thrombosis were identified.The patient status was stable.
Additional Manufacturer Narrative
An event of device migration and thrombus was reported.A returned device assessment could not be performed as the device remains implanted and 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.Based on the information received, the cause of the reported device migration and thrombus could not be conclusively determined.The unexpected medical intervention was result of medication administered.There were no complaints associated with any other devices from the lot.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 ; +1(651)756-5400
• MDR Report Key: 25638651
• Report Number: 2135147-2026-04395
• Device Sequence Number: 13143209
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)300630(10)10963370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-016
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 10963370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 07/11/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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 Sex: Unknown