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

Model Number 9-ASD-032

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Chest Pain (1776); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/09/2014

Event Type  Injury  

Event Description

A 32mm amplatzer septal occluder (aso) was successfully implanted.Over five years later, the patient presented to the emergency room with severe thoracic pain and went into cardiac arrest.Cpr was successful and the patient was transported to the cath lab.A pericardial effusion was observed which led to cardiac tamponade so pericardiocentesis was performed and 450cc of blood was removed.A cat scan revealed erosion in the aorta reportedly due to the aso.The patient was referred for emergency surgery where the aso was explanted, a pericardial patch was used to repair the septum, an aortic ring was repaired and the aorta was sutured.

• 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: 4206685
• MDR Text Key: 5038840
• Report Number: 2135147-2014-00100
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PP000039
• 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: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/03/2009
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: M06J18-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2006
• 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
• Patient Age: 70 YR