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 Code	Angina (1710)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 12mm amplatzer septal occluder was chosen for implant using a 7f amplatzer trevisio intravascular delivery system.The size of the defect was 10mm and the sizing of the device was determined by 18mm sizing balloon.The occluder was implanted and a tug test was performed.On (b)(6) 2025, the patient had chest pain and transesophageal echocardiogram (tee) showed the occluder was embolized into the aorta and the patient underwent a surgery.The physician mentioned the cause of embolization was the septum was really thin, so probably not enough stability.The patient was reported stable and discharged, septum was closed during surgery.
Additional Manufacturer Narrative
An event of device embolization into aorta, and angina, 1 day post amulet implant was reported.Possible contributing factors for device embolization include, incorrect sizing, difficulty implanting device and challenging anatomy.Information from field indicated that the sizing of the device was determined by sizing balloon.Field indicated that there was no difficulty implanting the device, and tug test performed adequately.The user alleged that the cause of embolization was the patient's septum was really thin, so probably not enough stability.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 of the reported embolization is possibly related to anatomical factor (septum was thin).However, the exact cause could not be conclusively determined.The surgical intervention is a case-specific circumstance as septum was closed during surgery.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23006141
• Report Number: 2135147-2025-05086
• Device Sequence Number: 18763027
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: (01)00811806010090(17)300228(10)10781987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/17/2025

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-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 10781987
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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: Required Intervention
• Patient Sex: Unknown