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

Model Number	9-ASD-034
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	05/14/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported on (b)(6) 2025 a 34mm amplatzer septal occluder was selected for implant using a 12f amplatzer trevisio intravascular delivery system.During implant the occluder took on a cobra shape.The occluder was re-sheathed and deployed again; however, the cobra shape remained.The occluder was not released from the delivery cable.The occluder was removed from the patient and re-deployed outside, but the cobra shape still remained.The occluder was replaced with a new 34mm amplatzer septal occluder.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 adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.However, two images were received from the field, one image showing cobra deformation, and the other image showing deformed occluder from the loader.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.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.

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22161821
• Report Number: 2135147-2025-03009
• Device Sequence Number: 7422069
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)261231(10)8291311
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/09/2025

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-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 8291311
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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: 12F AMPLATZER TREV [9-ATV12F45/80, LOT: 10080364]
• Patient Age: 55 YR
• Patient Sex: Male