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

Catalog Number	9-ASD-036
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 36mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 13f amplatzer trevisio intravascular delivery system.The device was implanted.The patient had a pre-existing condition of atrial fibrillation.Fluoroscopy and echocardiogram (echo) was used during the procedure.The atrial septal defect was measured as 28mm in echo, 31.7mm on echo with a balloon at stop flow, and 37mm on angiography.Sizing was taken from the balloon measurement.The device was implanted.The decision was made to perform cardioversion.The cardioversion caused the device to embolize to the left atrium.The device was snared with a transcatheter snare and removed from the patient.A new 40mm amplatzer septal occluder was selected for implant.The device was implanted.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a device embolization into the left atrium was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Information from the field indicated that cardioversion was performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on received information the cause of the reported event was due to cardioversion but could not be conclusively determined.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: 19072987
• Report Number: 2135147-2024-01612
• Device Sequence Number: 6825601
• Product Code: MLV
• UDI-Device Identifier: 00811806010250
• UDI-Public: (01)00811806010250(17)270831(10)8685060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/27/2024

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 Catalogue Number: 9-ASD-036
• Device Lot Number: 8685060
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female