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

Model Number 9-ASD-024

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/15/2014

Event Type  Injury  

Event Description

After a 24mm amplatzer septal occluder (aso) was implanted it embolized into the left atrium and to the left ventricle.Efforts to percutaneously retrieve the aso failed.The patient was sent to surgery and the aso was surgically removed.

Manufacturer Narrative

The 24mm aso was received at sjm and decontaminated.The occluder was grossly and microscopically examined; one broken wire was found on the distal disc, and approximately 6 mm of the sewing thread on the distal disc was cut and missing from the device.This type of damage is consistent with snaring or complex removal of the device.It met dimensional specifications when measured with a calibrated caliper.The device was loaded into a test 9f loader, deployed, and retracted without difficulty or deformation, 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 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: 3610497
• MDR Text Key: 19195343
• Report Number: 2135147-2014-00007
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/17/2017
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 1201186323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2012
• 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: 53 YR