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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was implanted.Pre-procedural assessment documented left atrial appendage ostium dimensions of 14x19mm, and device sizing was determined using echocardiography and fluoroscopy.Intraprocedural imaging was performed with transesophageal echocardiography (tee), during which no rhythm change was observed and no peri-device leak was detected.At the 60-day follow-up on (b)(6) 2026, echocardiography identified the device in the descending aorta.The patient remained asymptomatic, with no clinical signs or symptoms, aside from elevated blood pressure.The device was determined to have completely dislodged from the intended implant site, with the implanter attributing the event to under sizing.The embolized device resulted in a partial obstruction of blood flow in the descending aorta.On (b)(6) 2026, the device was successfully removed percutaneously without complications.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of migration (device embolization) during a follow up procedure 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 for the reported migration could not be determined.It is possible due to procedural conditions (device under sizing) could have contributed to this event.However, this cannot be confirmed.The reported hypertension could not be determined.The reported hypertension, and obstruction/occlusion could not be determined.It is possible that it was related to device embolized; however, this cannot be confirmed.The reported unexpected medical intervention and hospitalization was a result of case-specific circumstances as the device was snared.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6)2025, a 22mm amplatzer amulet was implanted.Pre-procedural assessment documented left atrial appendage ostium dimensions of 14×19mm, and device sizing was determined using echocardiography and fluoroscopy.Intraprocedural imaging was performed with transesophageal echocardiography (tee), during which no rhythm change was observed and no peri-device leak was detected.\ at the 60-day follow-up on (b)(6) 2026, echocardiography identified the device in the descending aorta.The patient remained asymptomatic, with no clinical signs or symptoms, aside from elevated blood pressure.The device was determined to have completely dislodged from the intended implant site, with the implanter attributing the event to undersizing.The embolized device resulted in a partial obstruction of blood flow in the descending aorta.On (b)(6) 2026, the device was successfully removed percutaneously without complications.

• 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: 24597383
• Report Number: 2135147-2026-01577
• Device Sequence Number: 9561004
• Product Code: NGV
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2026
• 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): 07/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 11018519
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male