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

Model Number	9-ASD-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during procedure the patient developed an atrial fibrillation.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.There was no allegation of malfunction against the abbott device or procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported intervention was a result of case-specific circumstance as medication was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 20mm amplatzer septal occluder was successfully implanted in a patient.It's noted during procedure that the occluder initially exhibited a cobra deformation, but was recaptured and had normal configuration on the second deployment.Post-procedure, it was noted via electrocardiogram that the patient developed an atrial fibrillation rhythm disorder with a heart rate of 220 beats per minute.The patient was administered 500mg of cordarone.On return from catheterization, the atrial fibrillation spontaneously resolved.There was no prolonged hospital for monitoring of heart rhythm.The cause of the patient's atrial fibrillation is attributed to implant of the 20mm amplatzer septal occluder that was large for the patient's body surface area.The patient was discharged at the time of report.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22346897
• Report Number: 2135147-2025-03493
• Device Sequence Number: 8527022
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)281231(10)10160234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 10160234
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 23 KG