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 Problems Erosion (1750); Chest Pain (1776); Death (1802); Headache (1880); Seizures (2063); Brain Injury (2219); Cardiac Tamponade (2226)

Event Date 09/22/2014

Event Type  Death  

Event Description

A large atrial septal defect (asd) with no retroaortic rim and a floppy posterior rim was closed with a 28mm amplatzer septal occluder (aso) on (b)(6) 2014.The patient had atypical chest pain (with skin sensitivity) hours after the procedure which gradually subsided the day after the procedure.Repeated echocardiogram scans showed no pericardial effusion and the aso in good position, including towards the aorta.Severe migraine was present two days after the procedure and the patient was discharged.Recurrent chest pain occurred three days after the procedure but there was no contact with the medical team.Four days after the procedure, the patient experienced sudden onset of severe chest pain and seizures at home.An emergency echocardiogram thirty minutes later showed cardiac tamponade and circulatory collapse.Heart massage and surgical pericardiotomy with removal of pericardial blood was performed.The patient was then transported to another hospital for cardiopulmonary bypass surgery two hours later where the aso was removed and the defect was patched.According to the cardiac surgeon, the aso eroded the aortic wall.The patient sustained severe brain damage and died in the intensive care unit on (b)(6) 2014.

Manufacturer Narrative

(b)(4).Sjm could not evaluate the aso involved in this incident since it was not returned to us.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.

Manufacturer Narrative

This event was reviewed by the st.Jude medical erosion board and confirmed that erosion occurred.

• 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: 4169287
• MDR Text Key: 4870658
• Report Number: 2135147-2014-00101
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PP000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2017
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 1204241352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 60