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

Model Number	9-ASD-038
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	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025 , a 38 mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio delivery system.During the procedure, the waist and the second disc of the occluder did not conform to the desired shape.It was noted that it took a "goblet- like shape".It was attempted thrice and the device was removed.The device was rinsed in warm saline for 8 minutes and the device continued to exhibit undesired shaped.The procedure was completed using a 36mm amplatzer septal occluder.It was reported that there was no interaction with the cardiac structures during deployment and no angulation or kink were noticed in the delivery system.It is noted that there was no clinically significant delay and the patient remained hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.Imaging was received from the field, one image of the deformed device inside the patient and one video of the deformed device outside the patient.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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Additional Manufacturer Narrative
An event of device deformity was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Imaging was received from the field, one image of the deformed device inside the patient and one video of the deformed device outside the patient.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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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: 23174917
• Report Number: 2135147-2025-05523
• Device Sequence Number: 9630007
• Product Code: MLV
• UDI-Device Identifier: 00811806010267
• UDI-Public: (01)00811806010267(17)280930(10)10023081
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 12/23/2025

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-038
• Device Catalogue Number: 9-ASD-038
• Device Lot Number: 10023081
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 12/04/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/18/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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 TEVISIO DS (LOT: 10650655).
• Patient Sex: Female