MAUDE Adverse Event Report: Abbott Medical Amplatzer Septal Occluder; Transcatheter Septal Occluder

Model Number	9-ASD-018
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, an 18mm amplatzer septal occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.Ino issue was noted with the device during the procedure.It was further reported that approximately 24 hours later, the implanter performed a bubble study, which was positive.On (b)(6) 2026, post-procedure, the device was retrieved percutaneously.No adverse events, clinical signs, or symptoms were reported during or after the procedure or retrieval.The implanter considered the event to be related to the procedure rather than the performance of the device.The patient was reported to be stable.
Event or Problem Description
It was reported that on (b)(6) 2026, an 18mm amplatzer septal occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.No issue was noted with the device during the procedure.Approximately 24 hours post-implant, a bubble study was performed and demonstrated a large residual shunt at inferior side of the septum, with bubbles continuing to cross the defect.Based solely on these findings, the physician elected to retrieve the device.On (b)(6) 2026, the device was successfully retrieved percutaneously.No adverse events, clinical signs, or symptoms were reported during or after the implant procedure or retrieval.The physician indicated that the event was related to the procedure rather than device performance.The patient was reported to be stable.
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.
Additional Manufacturer Narrative
An event of residual shunt post implant was reported.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.The cause for the reported residual shunt could not be determined.It is possible due to procedural condition; however, this cannot be confirmed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: health effect-clinical code: 4580.

• 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 ; +1(651)756-5400
• MDR Report Key: 50379419
• Report Number: 2135147-2026-05762
• Device Sequence Number: 13202522
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)310228(10)11323373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 11323373
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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 Age: 56 YR
• Patient Sex: Unknown
• Patient Race: White