MAUDE Adverse Event Report: AGA MEDICAL CORPORATION 24MM AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-024

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Erosion (1750)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 24mm amplatzer septal occluder (aso) was successfully implanted on (b)(6) 2017 after measuring the defect at 23.74 and 22.8mm in angiography and 21.4mm on tee with a stop flow sizing balloon.Of note, the atrial septal defect (asd) had a deficient retroaortic rim.The patient had a follow up tte on (b)(6) 2017, the aso looked normal accept for an inferior leak around the device.On (b)(6) 2017, the patient presented to the er with chest pain.Echo showed a pericardial effusion.The aso looked normal and unchanged.The patient was taken to surgery where the aso was visible through the superior portion of the right atrial wall near the aorta.The right atrial disc of the aso had eroded through the right atrial wall.The aso was removed, a patch was placed, and the eroded right atrial was sewn closed.

• Brand Name: 24MM 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: 6892242
• MDR Text Key: 87294206
• Report Number: 2135147-2017-00126
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 5591674
• Other Device ID Number: 00811806010199
• 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
• Date Device Manufactured: 08/03/2016
• 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: 12 YR