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

Model Number 9-ASD

Device Problem Unintended Movement (3026)

Patient Problem Congenital Defect/Deformity (1782)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the asos were not returned for evaluation.A review of the device history records could not be completed because the batch/lot numbers were not provided.There was no evidence to suggest there was an intrinsic defect in the occluders, and the cause for the reported events remains unknown.

Event Description

The following information was obtained from the "international heart journal" vol.56 no.4 2015, page 428-431.From june 2003 to june 2013, a total of 213 patients (115 adults and 98 children) diagnosed with secundum atrial septal defects (asd) underwent transcatheter closure of their defects with an atrial septal occluder (aso).The aso was implanted under transesophageal echocardiography (tee) guidance.Ten of 203 patients experienced aso dislodgement.All 10 patients had surgical removal of the asos and their statuses are good.No further information is expected to be received.

• 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: 5001913
• MDR Text Key: 22945854
• Report Number: 2135147-2015-00091
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention