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

Catalog Number	9-ASD-018
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	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 18 mm amplatzer septal occluder was selected for implant.During the procedure, it was noted that the device presented in a cobra deformation.The device was removed and replaced with another 18 mm amplatzer septal occluder to resolve the event.The device was never detached from the delivery cable, there was no interaction with any cardiac structures, or angulation/kink in the delivery system.The procedure was completed with no clinically significant procedure delay.The patient remained hemodynamic stable throughout procedure and with no adverse consequences.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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.Two photos, and one video were received from the field, showing the device deformity.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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The cause of the deformation could not be conclusively determined.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 18mm amplatzer septal occluder was selected for implant.During the procedure, it was noted that the device presented in a cobra deformation.The device was removed and replaced with another 18mm amplatzer septal occluder to resolve the event.The device was never detached from the delivery cable, there was no interaction with any cardiac structures, or angulation/kink in the delivery system.The procedure was completed with no clinically significant procedure delay.The patient remained hemodynamic stable throughout procedure and with no adverse consequences.

• 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: 21143801
• Report Number: 2135147-2025-00298
• Device Sequence Number: 9236851
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)281231(10)10157670
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/19/2025

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 Catalogue Number: 9-ASD-018
• Device Lot Number: 10157670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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