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

Model Number	9-ASD-020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erosion (1750); Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/25/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 20mm amplatzer septal occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.Prior to procedure, the patient's condition was good.No pericardial effusion was observed prior to procedure."various stability tests were performed," and the occluder was released for implant.Post-implant, no pericardial effusion was observed.The patient was reported to have been doing well in the afternoon following implant.On (b)(6) 2025, in the morning, cardiac tamponade was observed.Ultrasound was performed, which showed circumferential pericardial effusion that was subsequently drained successfully and the patient stabilized.However, approximately one hour later, a second tamponade was observed and the patient experienced cardiac arrest.Thoracic surgery attempted to open the chest to view the wound but noted pulsatile red blood ejection.The patient was reported to have passed.The cause of death was suspected as "probably aorta erosion.".
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer septal occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.Prior to procedure, the patient's condition was good.No pericardial effusion was observed prior to procedure."various stability tests were performed," and the occluder was released for implant.Post-implant, no pericardial effusion was observed.The patient was reported to have been doing well in the afternoon following implant.On (b)(6) 2025, in the morning, cardiac tamponade was observed.Ultrasound was performed, which showed circumferential pericardial effusion that was subsequently drained successfully and the patient stabilized.However, approximately one hour later, a second tamponade was observed and the patient experienced cardiac arrest.Thoracic surgery attempted to open the chest to view the wound but noted pulsatile red blood ejection.The patient was reported to have passed.The cause of death was suspected as "probably aorta erosion.".
Additional Manufacturer Narrative
An event of circumferential pericardial effusion, cardiac tamponade, patient death one day post septal occluder implant was reported.The presumed cause of death was reported as aorta erosion.Information from field indicated that pfo closure was attempted initially using an 30-25 mm amplatzer talisman pfo occluder, however, the device was not stable, and a decision was made to implant an aso.The device remained implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of reported incident and patient effects could not be determined.Based on the information received and medical review, 20 mm aso to close the pfo in this patient was too large for the encountered anatomy and resulted in impingement into the aorta with subsequent erosion.However, this could not be confirmed.The reported patient effects of pericardial effusion, cardiac tamponade, erosion, cardiac arrest and patient death appear to be a cascading effect.The reported unexpected medical intervention is a result of case-specific circumstance as pericardiocentesis was performed to drain the effusion.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 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: 22534572
• Report Number: 2135147-2025-03895
• Device Sequence Number: 12618840
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)270131(10)8334214
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 8334214
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Death
• Patient Age: 65 YR
• Patient Sex: Unknown