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

Model Number 9-ASD-010

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Injury (2348)

Event Date 10/22/2014

Event Type  Injury  

Event Description

During an atrial septal defect (asd) case, an 11mm amplatzer septal occluder (aso) device was placed across the septum but would not sit in the correct alignment.The 11mm aso device was difficult to recapture within the original 7f delivery system.Therefore, a 12f exchange system was used to retrieve the 11mm device and deploy a 10mm aso device.The 10mm device was deployed across the septum and released after a stability test was performed.Post deployment, the 10mm device embolized and was visualized in the pulmonary artery.The device was unable to be retrieved and the patient required surgical intervention for device removal and repair of the asd.It was reported the surgery went well.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation confirmed the 10 mm 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 of 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 ; 6517565400
• MDR Report Key: 4267104
• MDR Text Key: 19405018
• Report Number: 2135147-2014-00117
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP000039
• 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: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 4522593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 112