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

Model Number 9-ASD-034

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fistula (1862); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch: mw5071310.The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 34 mm amplatzer septal occluder (aso) was implanted (b)(6) 2012.One to two days before (b)(6) 2017 the patient experienced chest discomfort after heavy exertion.The patient collapsed, was brought to the emergency room, and found to be hypotensive.A cat scan showed moderate pericardial effusion with pericardial tamponade.Emergency surgery was performed by a subxiphoid window with pericardial biopsy and a blake pericardial drain was placed.While in icu, over several hours, more than a liter of blood was drained and open heart surgery was required.There was active bleeding seen from the posterolateral aspect of the aortic root just above the aorto-atrial junction.The right atrium was explored and the atrial septum was intact with the aso in place.The aso was removed.The surgeon could not see the specific tract going up into the aortic root but suspected that the aso put pressure on the roof of the left atrium which led to the development of a fistula into the adventitial tissues of the aortic root.The roof of the left atrium was closed as well as the septum.The patient's hemodynamics remained stable and they were transferred to the icu for monitoring.

• 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: 6853366
• MDR Text Key: 85457157
• Report Number: 2135147-2017-00107
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2017

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: 06/04/2015
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 1006043525
• Other Device ID Number: 00811806010243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2010
• 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