MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCC 11MM PKG STER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-011

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 08/27/2014

Event Type  Injury  

Event Description

An atrial septal aneurysm was balloon-sized to 11mm.A 11mm amplatzer septal occluder (aso) was deployed in the aneurysm.When the aso was released from the delivery cable the right atrial disc migrated to the left atrium.The decision was made to remove the aso and place a larger one.While attempting to percutaneously retrieve the aso, it embolized to the descending aorta where it was retrieved with a gooseneck snare without complications.

Manufacturer Narrative

The 11mm amplatzer septal occluder (aso) was received at sjm for analysis and decontaminated.The aso was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications when measured with a caliper.The aso was loaded into a test 7f 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.The results of this investigation confirmed the aso 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 OCC 11MM PKG STER
• 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: 4102959
• MDR Text Key: 4718411
• Report Number: 2135147-2014-00087
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP000039
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: 9-ASD-011
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 4415013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2013
• 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