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

Model Number	9-ASD-028
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Premature Separation (4045)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
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) 2025, a 28mm amplatzer septal occluder was chose for implant using a 10f amplatzer trevisio intravascular delivery system.The delivery cable and device were locked to prevent detachment before procedure.But the occluder was self-detached from the cable during the procedure, and the device was implanted in the patient.Posterior rim leak was revealed from post-procedure emergency transesophageal echocardiogram (tee), and computed tomography (ct) imaging showed signs of device closure site dehiscence.The patient is scheduled for hospitalization and surgical device removal in (b)(6).
Additional Manufacturer Narrative
An event of residual shunt and premature separation during procedure was reported.A returned device assessment could not be performed as the device remained implanted and 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 premature separation could not be conclusively determined.It is possible due to procedural conditions when performing the push and pull maneuver of the device which may have caused the reported incident.However, this cannot be confirmed.There were no complaints associated with any other devices from the lot.The reported hospitalization or prolonged hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Additionally, the imaging provided by the account were further reviewed by an abbott staff: video shows the occluder prior to reaching the end of the delivery sheath and it can be seen that the cable is not aligned with the proximal end screw of the occluder indicating that the delivery cable was already detached at this point.
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: 23322850
• Report Number: 2135147-2025-05885
• Device Sequence Number: 9948674
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)290831(10)10537118
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/12/2025

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 Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 10537118
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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: 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYST.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 35 YR
• Patient Sex: Unknown