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

Catalog Number	9-ASD-008
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an 8mm amplatzer septal occluder was selected for implant on (b)(6) 2024 to treat an atrial septal defect.Transesophageal echocardiography (tee) measured the defect as 5-7mm and according to a sizing balloon it was 7mm.Angiography and tee were used during the procedure.A stability check was performed.During the procedure it was noted that upon releasing the occluder from the delivery cable, the occluder embolized to the left atrium.The occluder was able to be removed from the patient with a transcatheter snare.A new non-abbott pfo occluder was implanted.There patient did not present with any clinical signs or symptoms.The user believed the embolization occurred due to the device sizing too small and imaging not properly done.The patient status was stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) 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.It was believed that the embolization occurred due to the device sizing too small and imaging was poor.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, a cause for the reported device embolization was due to mis-sizing the device.The reported unexpected medical intervention was a result of case-specific circumstances as a device was snared to explant the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that an 8mm amplatzer septal occluder was selected for implant on (b)(6) 2024 to treat an atrial septal defect.Transesophageal echocardiography (tee) measured the defect as 5-7mm and according to a sizing balloon it was 7mm.Angiography and tee were used during the procedure.A stability check was performed.During the procedure it was noted that upon releasing the occluder from the delivery cable, the occluder embolized to the left atrium.The occluder was able to removed from the patient with a transcatheter snare.A new non-abbott pfo occluder was implanted.The patient did not present with any clinical signs or symptoms.The user believed the embolization occurred due to the device sizing too small and imaging not properly done.The patient status was stable.

• 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: 21138406
• Report Number: 2135147-2025-00271
• Device Sequence Number: 20539409
• Product Code: MLV
• UDI-Device Identifier: 00811806010052
• UDI-Public: (01)00811806010052(17)261031(10)8218189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/06/2025

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 Catalogue Number: 9-ASD-008
• Device Lot Number: 8218189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• 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: 10F AMPLATZER TORQ DS[9-ITV-10F45/80, LOT: 811862]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown