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

Catalog Number	9-ASD-011
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/26/2024
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 on (b)(6) 2024, an 11mm amplatzer atrial septal defect (asd) occluder (lot: 8025259) was implanted successfully utilizing an 8f amplatzer trevisio delivery system.The size of the asd was 6mm per transesophageal echocardiogram (tee).The patient was experiencing short term discomfort while running.On (b)(6) 2024, during a follow-up transesophageal echocardiogram (tee), the occluder was observed to be detached and located in the abdominal aorta.The patient was admitted to the hospital.On (b)(6) 2024 the occluder was removed from patient using a transcatheter snare.The patient was reported to be stable and discharged.
Additional Manufacturer Narrative
An event of device embolization was reported.The field indicated that the defect was sized at 6mm and an 11mm aso was selected for closure.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.The cause of the reported event could not conclusively be determined but is likely due to incorrect device sizing.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.An 11mm aso was selected for closure of a defect sized at 6mm please note per the instructions for use, once the diameter of the defect is determined, select a device size equal to or 1 size larger than the diameter of the defect.Warning: do not select a device size that is more than 1.5 times the echocardiographic-derived asd diameter prior to balloon sizing.H6 medical device problem code: 2017 added.

• 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: 19784428
• Report Number: 2135147-2024-03488
• Device Sequence Number: 15546506
• Product Code: MLV
• UDI-Device Identifier: 00811806010083
• UDI-Public: (01)00811806010083(17)260531(10)8025259
• 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
• 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): 09/25/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 8025259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• 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: 8F AMPLATZER TREVISIO, 9-ATV08F45/80 LOT 8721513
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown