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

Model Number 9-ASD-018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since the batch/lot number is unknown.An event of erosion was reported.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

The information was obtained from the following literature article: scognamiglio g.Et al, "a very late life-threatening complication after percutaneous closure of an atrial septal defect." can j cardiol.2017 feb;33(2):293.E1-293.E2.At 5 years of age, the male patient underwent a successful implantation of an 18 mm amplatzer septal occluder (aso).Follow-up was uneventful, with serial transthoracic echocardiograms performed on a regular 2-year basis showing correct device position in the absence of residual shunting or any elements suggestive of procedure-related complications.However, 13 years later, at the scheduled assessment, the patient was fully asymptomatic, but the transthoracic echocardiogram showed an aneurysmal dilation of the ascending aorta with an intimal flap in its lumen.At (b)(6), the patient underwent a successful surgical repair with the removal of the aso, asd patch closure, and replacement of the ascending aorta with a polyester graft.Intraoperative findings confirmed erosion of the right atrial roof extending to the adjacent aortic wall at the level of the noncoronary sinus caused by a partial protrusion of the aso atrial disc.At the 1-year assessment, the patient was in good health.Patient identifier and weight is protected under local privacy laws, and therefore is not recorded.

• 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: 7148829
• MDR Text Key: 95855135
• Report Number: 2135147-2017-00192
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• 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; Required Intervention
• Patient Age: 20 YR