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

Model Number	9-ASD-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 32mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system.Transesophageal echocardiography measured the defect at 28 mm, and stop-flow balloon sizing measured 30 mm, with adequate rims except for an anterior defect where the aortic rim measured 5 mm.The initial device 32mm amplatzer septal occluder was deployed but residual flow persisted, prompting exchange for a larger 34mm amplatzer septal occluder , which was delivered after several attempts and appeared stable on imaging in multiple views.The device was released following confirmation of position and flow elimination.Later that day, embolization of the device was reported, the device had completely dislodged from its implant site and travel to the left atrium in the patient's anatomy.The patient underwent surgical closure with removal of the occluder.The physician believed the cause of the embolization was aneurysmal septum.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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) 2025, a 32mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system.Transesophageal echocardiography measured the defect at 28 mm, and stop-flow balloon sizing measured 30 mm, with adequate rims except for an anterior defect where the aortic rim measured 5 mm.The initial device 32mm amplatzer septal occluder was deployed but residual flow persisted, prompting exchange for a larger 34mm amplatzer septal occluder , which was delivered after several attempts and appeared stable on imaging in multiple views.It was noted that it took some manupulation to catch th eaortic rim to psoition the device.The device was released following confirmation of position and flow elimination.Later that day, embolization of the device was reported, the device had completely dislodged from its implant site and travek to the left atrium in the patient's anatomy.The patient underwent surgical closure with removal of the occluder.The physician believed the cause of the embolization was aneurysmal septum.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of device embolization 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device embolization could not be determined.It is possible that under sizing contributed to the event, however this cannot be determined.A prolonged hospitalization and surgical intervention were result of case-specific circumstances, as device was removed surgically.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23809473
• Report Number: 2135147-2025-07365
• Device Sequence Number: 12689723
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)290930(10)10555500
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/10/2026

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 Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 10555500
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 12 F AMPLATZER TREVISIO DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female