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

Model Number	9-ASD-014
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 14mm amplatzer septal occluder was chosen for implant using an unknown delivery system.The amplatzer septal occluder was implanted following a mitral clip procedure in mitral valve leaflet.Transesophageal echocardiography (tee) was used during the procedure.The implanter believed the cause of the subsequent device embolization was undersizing and the location of the device.Following implantation, the device completely dislodged from the intended implant site and embolized.The embolization was not identified intraprocedurally and became known as a post-procedural event.Transthoracic echocardiography (tte) identified the device embolization.To address the embolized device, surgical retrieval was performed.It was reported that the patient had experienced a mitraclip-related leaflet tear and the asd device had been used on the leaflet.The patient also had other issues related to the mitraclip procedure.
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.

• 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: 50819142
• Report Number: 2135147-2026-06310
• Device Sequence Number: 18694761
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: (01)00811806010113(17)300430(10)10863228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• 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-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 10863228
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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 Sex: Unknown