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

Model Number 9-ASD-020

Device Problems Break (1069); Defective Device (2588)

Patient Problems Erosion (1750); Pericardial Effusion (3271)

Event Date 04/09/2014

Event Type  Injury  

Event Description

A patient with a 20mm amplatzer septal occluder (aso) that was implanted approximately nine years ago presented with pericardial effusion.The patient was sent to surgery were the aso was removed and the defect and damage were repaired.The physician alleged the aso eroded through the roof of the left atrium.The patient was recovering in the icu on (b)(6) 2014.The event date is an estimation.

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis.Review of the device history record was not possible since the lot number was unavailable.The cause for the reported event remains unknown.This event was reviewed by the (b)(4) 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: 3764636
• MDR Text Key: 20299602
• Report Number: 2135147-2014-00037
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000039
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention