MAUDE Adverse Event Report: Abbott Medical Amplatzer Septal Occluder; Transcatheter Septal Occluder

Model Number	9-ASD-015
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2024, a 15 mm amplatzer septal occluder was implanted into patient.On (b)(6) 2026, it was discovered that the device was embolized into abdominal aorta which was known through echocardiography.
Additional Manufacturer Narrative
An event of a device embolization as 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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported device embolization could not be determined.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) 2024, a 15 mm amplatzer septal occluder was implanted in the patient using an 8f amplatzer trevisio intravascular delivery system.Intracardiac echocardiography (ice) was used as the imaging modality during the implant procedure.On (b)(6) 2026, during an echocardiographic examination, the device was identified as having embolized to the abdominal aorta.It was reported that the embolized device did not result in a partial or complete obstruction of blood flow.No additional information was provided.

• Brand Name: Amplatzer Septal Occluder
• Common Device Name: Transcatheter Septal Occluder
• 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: 50261413
• Report Number: 2135147-2026-05619
• Device Sequence Number: 10688114
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: (01)00811806010120(17)260228(10)7887964
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/22/2026

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 Expiration Date: 02/28/2026
• Device Model Number: 9-ASD-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 7887964
• 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: 08/14/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• 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: Other
• Patient Sex: Unknown