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

Catalog Number	9-ASD-020
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	02/24/2025
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) 2025, a 20mm amplatzer septal occluder was selected for implant using a 9f amplatzer trevisio delivery system.The defect was balloon-sized to 20mm but had a 3mm aortic rim; transesophageal echocardiogram (tee) was also used.During procedure, the occluder was deployed in the left atrium.However, the left disc experienced a cobra deformation that persisted despite attempts to re-form the device.The occluder was never released from the delivery cable and removed from the patient.A new 22mm amplatzer septal occluder was then attempted to be implanted using the same trevisio delivery system.However, this device also deformed with a cobra shape.The 22mm occluder was never released from the delivery cable and removed from the patient.There were no interactions with cardiac structures during deployment and no kink/angulation was observed with the delivery system.It was exchanged for another 22mm amplatzer septal occluder, which was successfully implanted using the same trevisio delivery system.The patient never experienced a rhythm change during procedure and remained hemodynamically stable throughout the procedure.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of device deformity did not confirm.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 defined manufacturing specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with regards 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: 21610421
• Report Number: 2135147-2025-01319
• Device Sequence Number: 15347011
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)281231(10)10141221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/26/2025

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-020
• Device Lot Number: 10141221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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: 16 YR
• Patient Sex: Female