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

Model Number	9-ASD-006
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning 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, an 8mm amplatzer septal occluder was selected for implant in a patient using a 9f amplatzer trevisio intravascular delivery system.The occluder was being used to treated a atrial septal defect.It was noted during procedure that the occluder a deformation when deployed.Echocardiography was used to confirm the deformation of the 8mm amplatzer septal occluder while it was inside the patient.There was contact with intracardiac structures during the deployment.The type of deformation observed was elongation.The decision was made to recaptured the occluder.The deformed occluder was retrieved from the patient prior to release from the delivery cable inside the patient.There were no bends or kinks observed in the delivery system.A replacement 18mm amplatzer cribriform occluder was prepared and successfully implanted using the same delivery system.The patient experienced no clinical signs or symptoms during or after the event, and there was no clinically significant delay in the procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of device deformity was reported.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from the field indicated there were no bends or kinks observed in the delivery system.There was contact with intracardiac structures during the deployment.Please note that per the instructions for use, the recommended size delivery system for use with a 6 mm septal occluder is an 6f.A 9f sheath was used to deliver the device.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.Based on the information received, the cause of the reported device deformity could not be conclusively determined.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.
Event or Problem Description
It was reported that on (b)(6) 2025, an 6mm amplatzer septal occluder was selected for implant in a patient using a 9f amplatzer trevisio intravascular delivery system.The occluder was being used to treated a atrial septal defect.It was noted during procedure that the occluder a deformation when deployed.Echocardiography was used to confirm the deformation of the 8mm amplatzer septal occluder while it was inside the patient.There was contact with intracardiac structures during the deployment.The type of deformation observed was elongation.The decision was made to recaptured the occluder.The deformed occluder was retrieved from the patient prior to release from the delivery cable inside the patient.There were no bends or kinks observed in the delivery system.A replacement 18mm amplatzer cribriform occluder was prepared and successfully implanted using the same delivery system.The patient experienced no clinical signs or symptoms during or after the event, and there was no clinically significant delay in the procedure.The patient was discharged at the time of report.No additional information was provided.

• 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: 22690520
• Report Number: 2135147-2025-04298
• Device Sequence Number: 15520833
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: (01)00811806010038(17)290831(10)10524658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-006
• Device Catalogue Number: 9-ASD-006
• Device Lot Number: 10524658
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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
• Patient Sex: Unknown