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

Model Number	9-ASD-015
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/03/2025
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 on (b)(6) 2025 a 15mm amplatzer septal occluder was selected for implant to treat an atrial septal defect (asd).The occluder was implanted.On (b)(6) 2025 a small aorta to left atrium shunt was observed.An aortography confirmed a 0.5mm shunt caused by erosion of the aorta with the left atrial disc of the occluder.On (b)(6) 2025 the occluder was surgically explanted and the asd was surgically closed.The patient status was stable.
Additional Manufacturer Narrative
An event of patient-device incompatibility (tissue erosion) and patient device interaction problem (residual shunt) was reported.Imaging was received from the field and a cine review was completed stating: "fluoroscopy imaging provided of implant and follow up.Aorta angiography shows close proximity of occluder to aorta but unable to visualize the small shunt." 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, a cause for the reported residual shunt and tissue erosion could be related to anatomical circumstances, however this could not be confirmed.The event of a prolonged hospitalization and surgical intervention of removal of the device and closure of the asd, was likely a cascading effect of tissue erosion.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 on (b)(6) 2025 a 15mm amplatzer septal occluder was selected for implant to treat an atrial septal defect (asd).The occluder was implanted.On (b)(6) 2025 a small aorta to left atrium shunt was observed.An aortography confirmed a 0.5mm shunt caused by erosion of the aorta with the left atrial disc of the occluder.On (b)(6) 2025 the occluder was surgically explanted and the asd was surgically closed.The patient status was stable.

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23160740
• Report Number: 2135147-2025-05485
• Device Sequence Number: 13298458
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: (01)00811806010120(17)270630(10)8572960
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P000039
• 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): 11/18/2025

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-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 8572960
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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: 6 YR
• Patient Sex: Female