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

Model Number 9-ASD-030

Device Problem Extrusion (2934)

Patient Problem Erosion (1750)

Event Date 12/22/2013

Event Type  Injury  

Event Description

A 30mm amplatzer septal occluder (aso) was successfully implanted in 2008; however, in december 2013 the patient presented to the emergency room with pericardial effusion and signs of possible device erosion on the roofs of both atria.Pericardiocentesis was performed, the aso was explanted and the atrial septal defect was surgically repaired.The patient was stabilized.

Manufacturer Narrative

Additional information: this event was reviewed by the st.Jude medical erosion board who confirmed that erosion occurred.

Event Description

A 30mm amplatzer septal occluder (aso) was successfully implanted in 2007; however, in (b)(6) 2013 the patient presented to the emergency room with signs of possible device erosion.The aso was explanted and the patient was stabilized.Limited details were reported and the implant, explant and event dates are estimates.

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis and the device's lot number was not provided which prevented us from being able to review the device history record.The cause of the reported event remains unknown.

• 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: 3584952
• MDR Text Key: 4153864
• Report Number: 2135147-2013-00136
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention