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

Model Number 9-ASD-024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Polymyositis (1992)

Event Date 08/05/2013

Event Type  Injury  

Event Description

A 24mm amplatzer septal occluder (aso) was successfully implanted in a large atrial septal defect in (b)(6) of 2013.A few days after the implantation the patient started to cough and experience interscapular myositis like pain which progressed to persistent chest pain, left mammary tenderness, shoulder pain and fatigue.Clinical evaluation and two echocardiograms showed successful defect closure with good aso placement.The patient underwent a true skin patch test which showed a nickel allergy.The patient was put on h2 blockers and two rounds of steroids but still has symptoms.The event date and implant date are estimations.

Manufacturer Narrative

The results of this investigation are inconclusive since the product remains implanted.The aso's manufacturing records could not be reviewed since the lot number was not provided.However, each aso is inspected by certified operators to ensure each lot is acceptable during manufacturing and prior to shipment.The cause of the reported event remains unknown.

• 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: 3840300
• MDR Text Key: 15327264
• Report Number: 2135147-2014-00052
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 05/16/2014

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 Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 05/30/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 31 YR