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

Model Number	9-ASD-004
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	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 4mm amplatzer septal occluder was selected for implant.During the procedure, when the device was deployed, it presented in a cobra deformation.The device was removed and new 4mm amplatzer septal occluder was attempted.It was found to be too small to push through the defect, so it was removed.A new 5mm amplatzer septal occluder was then selected for use.When attempted, the 5mm device was also found to be too small.There was also limited room in left atrium for a bigger device.The decision was made to surgically close the asd.No adverse events occurred with this patient this patient was hemodynamically stable throughout the procedure, the patient was on ecmo prior to procedure start.The patient is recovering in normal fashion.
Additional Manufacturer Narrative
The device is not returning for evaluation.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 was reported.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 specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 4mm amplatzer septal occluder was selected for implant.During the procedure, when the device was deployed, it presented in a cobra deformation.The device was removed and new 4mm amplatzer septal occluder was attempted.It was found to be too small to push through the defect, so it was removed.A new 5mm amplatzer septal occluder was then selected for use.When attempted, the 5mm device was also found to be too small.There was also limited room in left atrium for a bigger device.The decision was made to surgically close the asd.No adverse events occurred with this patient and they remained hemodynamically stable throughout the procedure, the patient was on ecmo prior to procedure start.There was no clinically significant delay during the procedure.The patient is recovering in normal fashion.

• 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: 21722738
• Report Number: 2135147-2025-01638
• Device Sequence Number: 9394546
• Product Code: MLV
• UDI-Device Identifier: 00811806010014
• UDI-Public: (01)00811806010014(17)290531(10)10396940
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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-004
• Device Catalogue Number: 9-ASD-004
• Device Lot Number: 10396940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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 Age: 1 MO
• Patient Sex: Female
• Patient Weight: 3 KG