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

Model Number 9-ASD-004

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2014

Event Type  Injury  

Event Description

A 4mm amplatzer septal occluder (aso) was selected to repair the patient's aorto-atrial fistula.The physician was aware this was an off-label use of the product.When the aso was released, it changed position and embolized to the femoral artery.The aso was successfully snared and removed.Subsequently, a closure device (8mm device, manufacturere unknown) was deployed without reported event.

Manufacturer Narrative

(b)(4).Sjm could not evaluate the product involved in this event since it was not returned to us.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation are inconclusive because the aso was not returned for evaluation.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause of the embolization 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: 4274205
• MDR Text Key: 5004140
• Report Number: 2135147-2014-00108
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/08/2017
• Device Model Number: 9-ASD-004
• Device Catalogue Number: 9-ASD-004
• Device Lot Number: 1205082037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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