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

Model Number	9-ASD-026
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
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 26mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery system to treat an atrial septal defect (asd).During the procedure the occluder took on a cobra shape.The occluder was released from the delivery cable.The occluder was snared and removed from the patient.The procedure was canceled, and the patient was transferred to surgery to close the asd.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a 26mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery system to treat an atrial septal defect (asd).During the procedure the occluder took on a cobra shape.The occluder was released from the delivery cable.The occluder was snared and removed from the patient.The procedure was canceled, and the patient was transferred to surgery to close the asd.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity and improper or incorrect procedure was reported.One photo was received from the field showing a cobra-like deformation on the device outside of the patient.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.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 deformity could be related to procedural circumstances, however this could not be confirmed.The reported improper or incorrect procedure or method is related to the device being released after non-conforming to it's original configuration.The unexpected medical intervention was a result of case-specific circumstances, as snaring of the device was successfully completed.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: 23337645
• Report Number: 2135147-2025-06003
• Device Sequence Number: 18507092
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: (01)00811806010205(17)290531(10)10383933
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/24/2025

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-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 10383933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 51 KG