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

Model Number	9-ASD-026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
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 26mm amplatzer septal occluder was implanted using an 10 f amplatzer trevisio delivery system.The patient is experiencing a persistent allergic reaction of unknown characteristics.The implanting physician did not know when the symptoms began but indicated that he was contacted several weeks after the symptoms had initiated.The patient is currently undergoing evaluation by an allergist/immunologist to determine whether the reaction may be related to metal or nickel sensitivity.The implanting physician is not aware of any results from the allergist and is not privy to additional information regarding potential metal or nickel allergy testing.There were no reports of anaphylactic shock; the implanting physician only described the reaction as ¿systemic.¿ the specific symptoms experienced by the patient were not known to the implanting physician.He was only informed that the patient was experiencing systemic reactions.No issues were observed during the implant procedure.No implant complications were reported at the time of the procedure.Additionally, there were no allegations of device malfunction or procedural concerns.It was also reported that there were no other known procedural objects that could have caused this event.The implanting physician reported that the patient remains stable and continues to be under the care of an allergist for further evaluation.
Additional Manufacturer Narrative
An apparent adverse event without identified device or use problem was reported with hypersensitivity/allergic reaction.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information and medical review, the cause for the reported hypersensitivity/allergic reaction could not be determined.A serious injury/illness/impairment was likely a result of case specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 24298511
• Report Number: 2135147-2026-00743
• Device Sequence Number: 9332255
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: (01)00811806010205(17)280630(10)9153054
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 9153054
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female