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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
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) 2025 a 34 mm amplatzer amulet left atrial appendage occluder (laao) was selected for implant using a 14f torqvue delivery sheath for a left atrial appendage (laa) closure.The imaging modality used for the procedure and to determine the device was transesophageal echocardiogram (tee).The device was resized and a 31 mm amplatzer amulet laao was selected for implant.The device was re-sheathed.The landing zone measurements at 0 degrees was 25 mm, 45 degrees was 20 mm, 90 degrees was 27 mm, and 135 degrees was 21 mm.During the procedure the left atrial pressure was below 12 mm hg.Fluid was given.The device was repositioned twice.Close criteria were met.A tension test was performed.The device was implanted.The device shape at the time of implant was roman helmet.At a follow up appointment on (b)(6) 2026, it was noted on tee the device shifted in position but was still implanted.The patient status was stable.
Additional Manufacturer Narrative
An event of device embolization was reported.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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, a cause for the reported embolization could be related to inadequate sizing and/or challenging anatomy, however this could not be confirmed.An unexpected medical intervention of eliquis was started.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 34 mm amplatzer amulet left atrial appendage occluder (laao) was selected for implant using a 14f torqvue delivery sheath for a left atrial appendage (laa) closure.The imaging modality used for the procedure and to determine the device was transesophageal echocardiogram (tee).The device was resized and a 31 mm amplatzer amulet laao was selected for implant.The device was re-sheathed.The landing zone measurements at 0 degrees was 25 mm, 45 degrees was 20 mm, 90 degrees was 27 mm, and 135 degrees was 21 mm.During the procedure the left atrial pressure was below 12 mm hg.Fluid was given.The device was repositioned twice.Close criteria were met.A tension test was performed.The device was implanted.The device shape at the time of implant was roman helmet.At a follow up appointment on 25 may 2026, it was noted on tee the device shifted in position but was still implanted.The patient status was stable.The patient was started on eliquis.

• 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: 25506055
• Report Number: 2135147-2026-04089
• Device Sequence Number: 10506163
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)260831(10)8140898
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8140898
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male