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

Model Number	9-ASD-028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Atrial Flutter (1730); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6).It was reported that on (b)(6) 2025, a 28mm amplatzer septal occluder was successfully implanted in a patient.It was reported that during procedure, the patient developed an onset of atrial fibrillation and flutter requiring a 150 joule electric shock and 150mg of cordarone to return to sinus rhythm.There was no difficulty implanting the 28mm amplatzer septal occluder.At an unknown point it was also noted that the patient developed left ventricular ejection fraction impairment.The patient was administered a 20mg furosemide bolus and began rapid progressive recovery with increased left ventricular filling pressures.On (b)(6) 2025, it was noted had developed acute renal failure with creatininemia.This resulted in prolonged hospitalization.The patient was hydrated and given a polyionic perfusion.The cause of the patient's intra-procedural atrial fibrillation/flutter is currently unknown.The cause of the patient's renal failure and left ventricular ejection fraction impairment are also currently unknown.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.No additional information was provided.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that during procedure the patient developed an onset of atrial fibrillation and flutter requiring a 150 joule electric shock, and medication was administered for patient to return to sinus rhythm.At an unknown point it was also noted that the patient developed left ventricular ejection fraction impairment.The patient developed acute renal failure with creatininemia on the following day of procedure that resulted in prolonged hospitalization.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.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 and rapid progressive recovery with increased left ventricular filling pressures was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There were no related complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22090289
• Report Number: 2135147-2025-02805
• Device Sequence Number: 6917149
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)271231(10)8835748
• 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,Followup
• Report Date (Section B): 06/13/2025

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-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8835748
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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 DS, 9-ATV12F45/80(LOT:10572643)
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 65 KG