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

Catalog Number	9-ASD-019
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422)
Date of Event	02/21/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm amplatzer septal occluder was chosen for implant using an 8f amplatzer trevisio intravascular delivery system.The patient was in sinus rhythm during procedure.The defect measured as 1.6mm on echocardiography.Echocardiographic and fluoroscopic guidance were used during procedure.There was difficulty implanting the device.The device was repositioned several times, and the edge of the inferior vena cava was left out.Finally the edges inside the device were visualized.A stability check was performed, and the device was implanted.Approximately 12 hours after implantation, the device embolized to the patient's left atrium.On 2024, the patient was taken to the procedure room to remove the device, and attempts were made to remove the device from the patient's heart via transcatheter snare.Venous access was made, and a temporary pacemaker was placed and resuscitated.The device had interaction with the mitral valve and travelled to the left ventricular outlet.The device caused an obstruction to blood flow at the left ventricular outlet.The device was attempted to be extracted but was not able to be recovered.The patient entered sustained low output and passed away.The cause of the embolization was believed to be that the edges of the cardiac structures had little firmness.
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, a 19mm amplatzer septal occluder was chosen for implant using an 8f amplatzer trevisio intravascular delivery system.The patient was in sinus rhythm during procedure.The defect measured as 1.6mm on echocardiography.Echocardiographic and fluoroscopic guidance were used during procedure.There was difficulty implanting the device.The device was repositioned several times, and the edge of the inferior vena cava was left out.Finally the edges inside the device were visualized.A stability check was performed, and the device was implanted.Approximately 12 hours after implantation, the device embolized to the patient's left atrium.On (b)(6) 2024, the patient was taken to the procedure room to remove the device, and attempts were made to remove the device from the patient's heart via transcatheter snare.Venous access was made, and a temporary pacemaker was placed and resuscitated.The device had interaction with the mitral valve and travelled to the left ventricular outlet.The device caused an obstruction to blood flow at the left ventricular outlet.The device was attempted to be extracted but was not able to be recovered.The patient entered sustained low output and passed away.The cause of the embolization was believed to be that the edges of the cardiac structures had little firmness.
Additional Manufacturer Narrative
An event of a device embolization into the left atrium 12 hours post implantation and death was reported.Information from the field indicated that there was difficulty implanting the device.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.However, a review of imaging received from the field and medical review were performed.The reviews revealed the cause of the reported device embolization was likely due to anatomical factors due to difficulty achieving a stable position along the ivc rim; and the cause of the reported death is due to technical difficulty in retrieving the device from the left heart.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19115552
• Report Number: 2135147-2024-01710
• Device Sequence Number: 20608592
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: (01)00811806010168(17)250731(10)7639347
• 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
• 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): 06/05/2024

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: 07/31/2025
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 7639347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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: Death
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 19 KG