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

Catalog 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	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2024, a 6mm amplatzer septal occluder was chosen for implant using a 7f amplatzer trevisio intravascular delivery system to close an atrial septal defect (asd).An 18mm sizing balloon was used to select the device size.During deployment of the device, it formed a cobra head deformation and could not be repositioned.Contact with intracardiac tissue occurred during the occluder deployment.The device was removed from the body to see if the deformation would revert, but it did not.There were no bends or kinks been observed in the delivery sheath.A new 6mm amplatzer septal occluder was successfully implanted using the same delivery system without any issues.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of device deformity was reported.Possible contributing factors of device deformity include use of the incorrect size delivery system and angulation or kink in the delivery system upon deployment.It was indicated that there were no bends or kinks been observed in the delivery sheath.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 available information and without the device to analyze, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20943086
• Report Number: 2135147-2024-06412
• Device Sequence Number: 20846692
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: (01)00811806010038(17)270228(10)8393025
• 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: 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): 01/02/2025

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-006
• Device Lot Number: 8393025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 12/28/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2022
• 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: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV07F45/80
• Patient Age: 41 YR
• Patient Sex: Male