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

Model Number	9-ASD-030
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Coronary obstruction/occlusion (4871)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, a 10mm and a 30mm amplatzer atrial septal occluder (aso) were chosen for implantation into a complex and fenestrated septum anatomy.A 34mm amplatzer sizing balloon was used.A 7f amplatzer treviso delivery sheath was utilizing with the 10mm aso and a 12f amplatzer trevisio delivery sheath was used with the 30mm aso.Both occluders passed the tension test and were deployed.The following morning, the patient was experiencing arrhythmia episodes when lying on side.Transesophageal echocardiogram (tee) was performed which revealed the 30mm occluder has embolized into the left ventricle.The 10mm occluder was still in place.Later that afternoon, surgical intervention was performed.Both occluders were removed and the septum was surgically corrected.There was no issue with the 10mm aso.The patient was reported to be hospitalized and recovering.
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 device embolization into the left ventricle causing a partial obstruction of blood flow, one day after the device 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 specifications.There were no complaints associated with any other devices from the lot.It is possible that patient's challenging anatomy could have contributed to this event.However, this cannot be confirmed.The reported hospitalization, and unexpected surgical intervention were a result of case-specific circumstances as a device was surgically removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes added: h6 health effect - clinical code: 4871 coronary obstruction/occlusion.
Event or Problem Description
Subsequent to the previously filed report, additional information was received.Transesophageal echocardiogram (tee) was performed which revealed the 30mm occluder has embolized into the left ventricle causing a partial obstruction of blood flow.The 10mm occluder was still in place.Later that afternoon, surgical intervention was performed.Both occluders were removed and the septum was surgically corrected.There was no issue with the 10mm aso.The patient was reported to be hospitalized and recovering.

• 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: 22044585
• Report Number: 2135147-2025-02621
• Device Sequence Number: 21052880
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: (01)00811806010229(17)290131(10)10192852
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 10192852
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10MM AMPLATZER SEPTAL OCCLUDER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female