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

Model Number	9-ASD-013
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
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) 2023, a 13mm amplatzer septal occluder was implanted into an atrial septal defect (asd) using a 9f amplatzer trevisio intravascular delivery system.The dimension of the asd was measured to be 11-14mm, which was determined via sizing balloon occlusion.On (b)(6) 2023, it was discovered on a routine transesophageal echocardiogram (tee) that the device had relocated anteriorly to an unstable position in the heart.The device had shifted such that the right atrial disc and left atrial disc were both in the left atrium.The patient did not complaint of any symptoms.The device was surgically explanted, and a surgical patch was applied to close the asd.The patient had prolonged hospitalization to recover from surgery.The cause of the migration was believed to be due to deficient posterior rim.The patient status was reported as stable.
Event or Problem Description
It was reported that on (b)(6) 2023, a 13mm amplatzer septal occluder was implanted into an atrial septal defect (asd) using a 9f amplatzer trevisio intravascular delivery system.The dimension of the asd was measured to be 11-14mm, which was determined via sizing balloon occlusion.On (b)(6) 2023, it was discovered on a routine transesophageal echocardiogram (tee) that the device had relocated anteriorly to an unstable position in the heart.The device had shifted such that the right atrial disc was partially in the left atrium.Some of the disc was still holding onto the septum.The patient did not complaint of any symptoms.The device was surgically explanted, and a surgical patch was applied to close the asd.The patient had prolonged hospitalization to recover from surgery.The cause of the migration was believed to be due to deficient posterior rim.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of device migration 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.Based on the information received, the cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.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: 16748608
• Report Number: 2135147-2023-01668
• Device Sequence Number: 3379417
• Product Code: MLV
• UDI-Device Identifier: 00811806010106
• UDI-Public: 00811806010106
• 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: 2023
• Device Explanted Year: 2023
• 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): 06/09/2023

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 Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 8212338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female