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

Model Number	9-ASD-024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/29/2025
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a 24mm amplatzer septal occluder was chosen for implant using a 12f amplatzer torqvue delivery system.The device was implanted.After the procedure, the patient passed away due to pericardial effusion.
Event or Problem Description
It was reported that on (b)(6) 2025, a 24mm amplatzer septal occluder was chosen for implant using a 12f amplatzer torqvue delivery system.The device was implanted.After the procedure, prior to leaving the cardiac catheterization lab a localized pericardial effusion was noted.A pericardiocentesis was performed.The patient passed away due to pericardial effusion on (b)(6) 2025.
Additional Manufacturer Narrative
An event of patient death due to pericardial effusion during device deployment in post-infact vsd case was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The event was further reviewed by an abbott director medical affairs.The reviewer noted: "the cause of death is reported to be procedure related and related to underlying comorbidities.A pericardial effusion may develop due to cardiac perforation which may occur due to instrumentation at the time of the implant procedure.The fragile myocardial tissue increases the risk for cardiac perforation.Event relationship: procedure related and related to underlying patient comorbidities.Not related to a device malfunction." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, and the cine review, the cause of the reported patient death could not be conclusively determined.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: 23378755
• Report Number: 2135147-2025-06065
• Device Sequence Number: 21132662
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: (01)00811806010199(17)270630(10)8551646
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/12/2025

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-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 8551646
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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: Death
• Patient Sex: Male