MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-032

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that the user believed this was most likely due to mis-sizing.

Event Description

On (b)(6) 2018, a 30mm amplatzer atrial septal occluder (aso) was selected.During the procedure, the 30mm aso deployed in a cobra shape and per the user, the deformation event did not have the potential to cause patient harm or injury.The device was exchanged for a second 30mm aso, which was considered a mis-sizing so the device was exchanged for a 32mm aso.The 32mm aso was deployed and released, but embolized after implantation.Again, per user, the embolization event was most likely due to mis-sizing of the device.The patient was referred to cardiac surgery where the embolized device was retrieved and the atrial septal defect was closed with a patch.The patient remained hemodynamically stable throughout the procedure and is reported stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8196075
• MDR Text Key: 131394674
• Report Number: 2135147-2018-00246
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 6603642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2018
• Date Device Manufactured: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR