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

Model Number 9-ASD-028

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Pericardial Effusion (3271)

Event Date 05/09/2014

Event Type  Injury  

Event Description

A 28mm amplatzer septal occluder (aso) was implanted successfully; however, five years later the patient presented to the hospital with syncope, hypotension and a pericardial effusion found on ct.Pericardiocentesis yielded 800ml of blood and device erosion of the left atrial roof into the aortic root was suspected.No obvious aortic invasion was reported but the posterior aortic wall appeared denuded.The patient's atrial septal defect was surgically closed using bovine pericardium and the left atrial roof and right atrium were repaired with a bovine pericardial patch.The aso was explanted, patient was removed from vasopressors and went into transient atrial fibrillation post-op but was otherwise stable.

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis and the lot number was not provided which prevented a review of the device history record.The cause of the reported event remains unknown.

Manufacturer Narrative

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.This event was reviewed by the st.Jude medical erosion board who 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: 3839506
• MDR Text Key: 4620747
• Report Number: 2135147-2014-00046
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/18/2013
• Device Model Number: 9-ASD-028
• Device Lot Number: M08E19-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2008
• 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: 66 YR
• Patient Weight: 54