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

Model Number 9-ASD-018

Device Problem Difficult to Remove (1528)

Patient Problem Embolism (1829)

Event Date 03/17/2014

Event Type  Injury  

Event Description

The patient's secundum atrial septal defect measured 13.5mm in diameter with a total septal length of 45mm.The stop-flow stretch diameter by echocardiogram and cine was 19-20mm in diameter.Initially, the atrial septal defect was closed using an 18mm amplatzer septal occluder (aso) after the push-pull technique demonstrated device stability; however, upon release the aso embolized into the left atrium and then into the left ventricle.The aso could not be retrieved through the 10f so it was exchanged for a 12f sheath which was used to successfully remove the device.The septal defect was found to be larger than previously anticipated and a 30mm aso was implanted successfully.

Manufacturer Narrative

The 18mm aso was returned to sjm and decontaminated.The aso was grossly and microscopically examined, and no anomalies were found.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 confirmed the amplatzer septal occluder met all functional and dimensional specifications when analyzed at sjm.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 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: 3730940
• MDR Text Key: 4329860
• Report Number: 2135147-2014-00028
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/20/2017
• Device Model Number: 9-ASD-018
• Device Lot Number: 1207136114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2012
• 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
• Patient Age: 7 MO