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

Model Number 9-PDA-005

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2014

Event Type  Injury  

Event Description

During a trans-apical left ventricular (lv) access procedure, an 8mm amplatzer vascular plug ii (avpii) was attempted without success as the avpii did not produce a good seal.Next, an 8/6mm amplatzer duct occluder (ado) was attempted using the avpii's cable.While positioning the ado and injecting contrast, however, the ado was prematurely released and embolized to the bifurcation of the common iliac.The ado's premature release was suspected to have been caused by cross-threading of the ado threads.The ado was snared and removed without issue.The lv defect was closed using a 12mm amplatzer septal occluder and surgiflow sealant.No adverse patient effects were reported.

Manufacturer Narrative

The 8/6 mm ado was returned to sjm and decontaminated.The device was examined grossly and microscopically, and was confirmed not to contain any defects or abnormalities.The device was confirmed to meet dimensional specifications when measured with a caliper.The ado was successfully deployed from a test 6f loader without any deformations, under non-physiological conditions.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.There was no evidence to suggest there was an intrinsic defect in the device, and the cause for the embolization remains unknown.

• Brand Name: AMPLATZER DUCT 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: 4029799
• MDR Text Key: 4800792
• Report Number: 2135147-2014-00078
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• 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
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• 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-PDA-005
• Device Lot Number: 4513191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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