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

Model Number 9-PDA2-04-04

Device Problems Premature Activation (1484); Device Operates Differently Than Expected (2913)

Patient Problem Embolism (1829)

Event Date 05/26/2015

Event Type  Injury  

Event Description

A 6-4mm amplatzer duct occluder ii (adoii) was attempted to be deployed but was mis-sized and removed still attached to the delivery cable.A 4-4mm adoii was then deployed but embolized into the pulmonary artery upon release from the cable.The adoii was percutaneously snared and removed and the patient was referred for surgical closure of the defect.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The 4-4 mm adoii was received in the postmarket surveillance lab and was decontaminated.The occluder was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications when measured with a caliper.The device was loaded into a test 5f loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.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 occluder 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 occluder, and the cause for the embolization 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: 4851338
• MDR Text Key: 16630068
• Report Number: 2135147-2015-00062
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 9-PDA2-04-04
• Device Catalogue Number: 9-PDA2-04-04
• Device Lot Number: 4482898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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: 3 YR
• Patient Weight: 19