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

Model Number 9-ASD-012

Device Problem Unintended Movement (3026)

Patient Problem Embolism (1829)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

Gtin number: unknown since the batch number was not provided.(b)(4) the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 12 mm amplatzer septal occluder (aso) was released from the delivery cable and embolized during the case.The aso was retrieved percutaneously and no complications where noted.It was believed the aso was to small for the defect.A larger 20 mm aso was used to close the defect.The patient was reported to be in stable condition.

• 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: 5986968
• MDR Text Key: 55918378
• Report Number: 2135147-2016-00094
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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