MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-020

Device Problem Unintended Movement (3026)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the aso was not returned for evaluation.A review of the device history record confirmed the aso met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the aso and the cause for the reported event remains unknown.

Event Description

The atrial septal defect was balloon-sized to 18 mm and a 20 mm amplatzer septal occluder (aso) was selected.The patient had minimal aortic rim and when the aso was deployed it did not appear fully secured on the aortic side.The aso was recaptured and repositioned.After the second deployment, the stability test was performed and the position confirmed as satisfactory so the aso was released.A few minutes after release the aso embolized into the aorta.The aso was percutaneously snared and removed and the patient was sent for surgical closure.The patient is reported to be stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5045818
• MDR Text Key: 24705698
• Report Number: 2135147-2015-00094
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 4897158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention