MAUDE Adverse Event Report: AGA MEDICAL CORPORATION; AMPLATZER DUCTAL OCCLUDER

Model Number ADO IIAS

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Product #1 pi main [(b)(4)].As reported in a research article, tricuspid regurgitation was a complication of the device implant procedure the results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A retrospective study on transcatheter pda closure in preterm infants.This study demonstrates that closure can be performed safely without contrast injection using echocardiographic guidance.Complications did not lead to permanent cardiac damage.The study included, ninety one ado ii as, 10 mvp, and 1 coil.No embolization's or residual shunt was reported.Ado ii devices were placed entirely within the pda without any disk in the pulmonary artery or in the aorta.Three patients were reported with left pulmonary artery stenosis.Two patients underwent surgical intervention to remove the device and one patient had a balloon dilation, good long-term reports resulted.The study confirms the high rate of technical success and provides descriptive clinical and outcome data.(pg.5).Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Type of Device: AMPLATZER DUCTAL 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9361657
• MDR Text Key: 169324340
• Report Number: 2135147-2019-00401
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ADO IIAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention