MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-012
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2021, a 12mm amplatzer septal occluder was implanted in the patient had an atrial septal defect (asd).The occluder was successfully implanted.After the procedure, the patient began to feel pain in legs, in addition to abnormal fatigue.During the investigation, they discovered that the amplatzer had moved through the aorta, having adhered to the artery wall near the celiac trunk.On an unknown date in (b)(6) 2022, there was an attempt to remove the amplatzer, but we were unsuccessful due to the product adhering to the artery walls, resulting in a high risk of rupture.On an unknown date in (b)(6) 2025, it was necessary to place bovine pericardium to close the septum via open surgery.
Additional Manufacturer Narrative
An event of device embolization, pain in the legs, and fatigue 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported fatigue and pain in the leg is likely a cascading effect of the reported device embolization.The cause of the reported.Device embolization could not be conclusively determined.The reported surgical and unexpected medical intervention were results of case-specific circumstances as an attempt to snare the device was performed and subsequently the atrial septal defect was closed with a bovine pericardium.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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 ; 6517565400
• MDR Report Key: 22592026
• Report Number: 2135147-2025-04073
• Device Sequence Number: 21095547
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: (01)00811806010090(17)230331(10)6431683
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/12/2025

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 Expiration Date: 03/31/2023
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 6431683
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2018
• 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: Female