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

Model Number 9-PDA2-04-04

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/17/2015

Event Type  Injury  

Event Description

The 4/4 mm amplatzer duct occluder ii (adoii) was placed in situ and released from the delivery cable.The aortic disc created a partial obstruction in the aorta, which increased with each cardiac cycle.The adoii was percutaneously removed during the implant procedure and replaced with two coils.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) - no consequences or impact to patient.Gradient increase.The results of this investigation confirmed the adoii met all functional and dimensional specifications when analyzed at sjm.A review of the device history record confirmed the adoii met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the adoii, and the cause for the reported event remains unknown.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 4665119
• MDR Text Key: 5604459
• Report Number: 2135147-2015-00043
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P020024/S037
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: 9-PDA2-04-04
• Device Catalogue Number: 9-PDA2-04-04
• Device Lot Number: 1205011831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 7