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	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm amplatzer amulet was implanted in the patient's body using a 14f amplatzer torqvue delivery sheath.The landing zone measurements used to determine device size were 22 mm at 0°, 18 mm at 45°, 28 mm at 90°, and 28 mm at 135°.Device sizing was based on the largest landing zone measurement plus 3 mm, and the ostium measured approximately 30¿32 mm.Transesophageal echocardiography (tee) was utilized during the procedure for imaging.The device was implanted in a ¿roman helmet¿ shape, and a tension test was performed.The patient¿s left atrial pressure at the time of the procedure was 11 mmhg, and normal fluid was administered during the procedure.Close criteria were satisfied.On (b)(6) 2025, during a 45-day follow-up, tee revealed that the device had migrated.The device had shifted within the landing zone but remained in the appendage; however, the disc was not fully engaged.The implanter attributed the migration to a calcified appendage and hyper-contractile atrial tissue.The intervention performed to address the migration was percutaneous retrieval.There were no additional adverse patient effects reported and patient is reported to be stable.
Additional Manufacturer Narrative
The device is not returning 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 device migration 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, the cause for the reported device migration could not be confirmed.An unexpected medical intervention was a result of case-specific circumstances, as snaring of the device was performed.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 that on (b)(6) 2025, a 31mm amplatzer amulet was implanted in the patient's body using a 14f amplatzer torqvue delivery sheath.The landing zone measurements used to determine device size were 22 mm at 0°, 18 mm at 45°, 28 mm at 90°, and 28 mm at 135°.Device sizing was based on the largest landing zone measurement plus 3 mm, and the ostium measured approximately 30¿32 mm.Transesophageal echocardiography (tee) was utilized during the procedure for imaging.The device was implanted in a ¿roman helmet¿ shape, and a tension test was performed.The patient¿s left atrial pressure at the time of the procedure was 11 mmhg, and normal fluid was administered during the procedure.Close criteria were satisfied.On (b)(6) 2025, during a 45-day follow-up, tee revealed that the device had migrated.The device had shifted within the landing zone but remained in the appendage; however, the disc was not fully engaged.The implanter attributed the migration to a calcified appendage and hyper-contractile atrial tissue.The intervention performed to address the migration was percutaneous retrieval.There were no additional adverse patient effects reported and patient is reported to be stable.

• 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: 23687944
• Report Number: 2135147-2025-07053
• Device Sequence Number: 5904957
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)271031(10)8745672
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8745672
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male