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

Model Number 9-ASD-028

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Erosion (1750)

Event Date 01/28/2017

Event Type  Injury  

Manufacturer Narrative

An event of effusion and 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

A 28mm amplatzer septal occluder (aso) was implanted on (b)(6) 2016.A follow up echo was performed on (b)(6) 2017 and the aso looked good.The next day(b)(6) 2017, the patient complained of chest pain, shortness of breath, and light-headedness.The patient presented to the er where an echo revealed a large effusion and the patient was sent to surgery.Surgery revealed a 7mm linear erosion of the left atrial disc of the aso in the posterior, superior left atrial wall.The aso was removed and a pericardial patch was used to close the atrial septal defect.The tear in the atrial wall was sewn together.

• 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 ; 6517565400
• MDR Report Key: 6951559
• MDR Text Key: 89382205
• Report Number: 2135147-2017-00136
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• 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): Required Intervention
• Patient Age: 26 YR