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

Model Number 9-ASD-011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Vomiting (2144)

Event Date 05/22/2014

Event Type  Injury  

Event Description

The night following the implantation of a 11mm amplatzer septal occluder (aso) the patient started vomiting.The next day during a valsava maneuver the aso was found to have embolized to the aorta.It was removed percutaneously with a lasso and a 22mm aso was successfully implanted.A sizing balloon was not used to measure the defect when implanting the 11mm aso but one was used when the 22mm aso was implanted.

Manufacturer Narrative

The 11mm aso was received at sjm and 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 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.A review of the device history record confirmed the aso 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 aso, and the cause for the embolization remains unknown, however, information from the field suggests the lack of the use of a sizing balloon resulted in under sizing of the device.

• 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 ; 6517565400
• MDR Report Key: 3886730
• MDR Text Key: 4672907
• Report Number: 2135147-2014-00059
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2014

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: 11/07/2017
• Device Model Number: 9-ASD-011
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 1212112553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2012
• 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: 10 YR
• Patient Weight: 50