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

Model Number 9-ASD-011

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Rupture (2208); Loss of consciousness (2418)

Event Date 03/21/2014

Event Type  Injury  

Event Description

An 11mm amplatzer septal occluder (aso) was implanted on (b)(6) 2013.On (b)(6) 2014 the patient loss consciousness after a bowel movement and was rushed to the hospital.Emergency surgery was performed and found that the right atrial disc of the aso compressed the aortic root which ruptured about 1.5cm.The aso was removed and the defect was closed with a patch and the tissue damage was repaired surgically.The patient was recovering well after the surgery.

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis.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.The cause for the reported event remains unknown.

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: 3704291
• MDR Text Key: 4252800
• Report Number: 2135147-2014-00031
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2014

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: Physician
• Device Expiration Date: 01/30/2017
• Device Model Number: 9-ASD-011
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 1202017037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 30 YR