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	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 31mm amplatzer amulet left atrial appendage occluder was implanted in the patient.The implanted amulet was embolized that evening.A transcatheter retrieval was performed but, unsuccessful so surgery is being considered.The amulet was currently in the left ventricle apex.
Event or Problem Description
It was reported that on (b)(6) 2026, a 31mm amplatzer amulet left atrial appendage occluder was implanted in the patient.The sizing of the device was determined by feops.During procedure, two different sized devices were attempted and this was the third attempt of the second size.The left atrial pressure was 10mmgh initially so saline was given, later over 12mmhg.The amulet was implanted after satisfying close criteria and tension test was performed.The shape of the device was marshmallow or slightly above, not a roman helmet.The implanted amulet was embolized that evening.A transcatheter retrieval was performed but, unsuccessful so surgery is being considered.The amulet was currently in the left ventricle apex.Later the device got removed and the patient was reported recovering.
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.
Additional Manufacturer Narrative
An event of migration or expulsion of device (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 specifications.Based on the information received, the cause of the reported device embolization cannot be conclusively determined.There were no complaints associated with any other devices from the lot.The reported that the unexpected medical intervention and surgical intervention results from case-specific circumstances, as the device was snared and explanted the device to address the embolization.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 ; +1(651)756-5400
• MDR Report Key: 50240604
• Report Number: 2135147-2026-05538
• Device Sequence Number: 10353387
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)300531(10)10907890
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 09/24/2026

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 10907890
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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
• Patient Sex: Unknown