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

Model Number 9-ASD-034

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Syncope (1610); Dyspnea (1816)

Event Type  Injury  

Event Description

The patient was implanted with a 34mm amplatzer septal occluder (aso) in 2003.Recently, the patient presented with shortness of breath and syncope.An mri demonstrated migration of the aso and imagery that was consistent with the aso being held in place by the inferior rim and a residual shunt.The patient was referred to surgery for explant of the aso and closure of the atrial septal defect.It is unconfirmed if the patient received follow-up echos post-implant to confirm placement post-implant.

Manufacturer Narrative

Gtin: not available as the lot and serial numbers are unknown.The device's manufacturing records could not be reviewed since the lot number was not provided.However, each device is inspected by certified operators to ensure each lot is acceptable during manufacturing and prior to shipment.The results of this investigation are inconclusive because the product was not returned for analysis and the device history record could not be reviewed.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 ; 6517564470
• MDR Report Key: 4345235
• MDR Text Key: 5220769
• Report Number: 2135147-2014-00124
• 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
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention