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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20 mm amplatzer amulet device was implanted using a 12f amplatzer amulet delivery sheath in a female patient with windsock anatomy.The landing zone was measured at 16 x 20 mm on computed tomography (ct) imaging.The patient was in sinus rhythm during the procedure.Device sizing was determined using ct, transesophageal echocardiography (tee), and angiography.The patient was in sinus rhythm during the procedure.Tee and angiography were used as imaging modalities during the procedure.The device initially appeared to be well positioned within the left atrial appendage, with the entire lobe inside the circumflex region and all closure criteria fulfilled.The device was in a tire shape at the time of implant, and no leak was detected around the lobe.A short tug test was performed to confirm stability.However, after release from the delivery cable, the device changed position.On tee and angiography, part of the lobe was seen protruding into the atrium, indicating migration.The physician attempted to retrieve the device using a snare, but the attempt was unsuccessful.The device shifted position within the intended implant site when released and embolized during the snaring attempt, eventually migrating into the ventricle.The implanter believed the cause of migration was sinus rhythm, as the device appeared well positioned at a 45° tee view but was seen protruding into the atrium at a 145° view.There was no difficulty with implanting the device, and no multiple recaptures or repositioning were required.Fluid administration included 500 ml of nacl at the start of the procedure.The patient was referred for surgical intervention.The procedure was performed under general anesthesia.After migration into the ventricle, the surgeon was consulted, and since the patient remained stable, surgery was scheduled for the next day.The operation was successful, with the device retrieved and the appendage closed by the surgeons.
Additional Manufacturer Narrative
An event of migration or expulsion of device 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 migration or expulsion of device could not be determined.Interventions were a result of case-specific circumstances, as an attempt to snare the device was unsuccessful and the device was removed surgically.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 23824959
• Report Number: 2135147-2025-07449
• Device Sequence Number: 20100532
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)291130(10)10632464
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/03/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10632464
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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; Other
• Patient Sex: Unknown