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

Model Number	9-ASD-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
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 an unknown delivery system to treat atrial septal defect (asd).During the procedure, upon release of device, the physician noted that the occluder shifted to the left atrial side of the aortic rim while remaining stable on the remaining rims.When the physician attempted to retrieve the device using a snare, the occluder was advanced completely into the left atrium.The device subsequently migrated into the left ventricle and then into the aorta.Femoral arterial access was obtained, and the physician successfully snared and retrieved the device.The patient was reported to be stable throughout the event.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 50819744
• Report Number: 2135147-2026-06324
• Device Sequence Number: 16121673
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)310228(10)11323373
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 09/18/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 231 LB