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

Catalog Number	9-ASD-009
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Vomiting (2144); Obstruction/Occlusion (2422)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 9mm amplatzer septal occluder was chosen for an atrial septal defect (asd) using a 7f amplatzer trevisio intravascular delivery system.The size of asd measured by echocardiogram (echo) was 6mm and the aortic edge was 6mm.During procedure, the occluder was placed echocardiography with good positioning, the minnesota maneuver was performed with good stability, the device was released, images are taken and the device was well implanted.Thirty-six hours later, patient started to vomit and a chest x-ray was conducted, the specialist called and informed the device was embolized to aorta.There was a partial obstruction due to the embolized device.The device was removed via percutaneous retrieval and new measurements were taken.No balloons were used, 3d echo was used and a larger measurement of 11mm was found.A new 14mm amplatzer septal occluder was chosen, well positioned and implanted.The patient required prolonged hospitalization.The patient was reported stable and sent to hospital for recovery.
Additional Manufacturer Narrative
An event of device embolization, partial obstruction, vomiting, hospitalization, and unexpected medical intervention was reported.The device was returned to abbott for investigation and the device met dimensional specifications when analyzed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause of the reported device embolization appears to be related to operational context (incorrect defect sizing).The partial obstruction was due to the device embolizing to the aorta.The cause of the vomiting could not be conclusively determined.The reported hospitalization and unexpected medical intervention were due to case-specific circumstances, as the device was snared and a replacement was implanted, requiring prolonged hospitalization.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 20396635
• Report Number: 2135147-2024-04935
• Device Sequence Number: 3492497
• Product Code: MLV
• UDI-Device Identifier: 00811806010069
• UDI-Public: (01)00811806010069(17)260930(10)8200504
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/27/2024

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: 09/30/2026
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 8200504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 15 KG