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

Model Number 9-ASD-026

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

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 serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information comes from the abstract titled "two cases of coronary artery fistula associated with deployment of amplatzer septal occluder (aso)." on an unknown date, a 26mm amplatzer septal occluder (aso) was implanted at the patient's atrial septal defect (asd) which was measured at 24.2mm.As the patient has a complication of pulmonary hypertension, she has regularly undergone coronary angiography (cag).Sixteen months after the aso was implanted, no anomalies were observed through cag.Fifteen six months after the aso was implanted, no elevation of pulmonary to systemic blood flow (qp/qs) ratio was noted.However, coronary artery fistula was confirmed from both the right and left coronary arteries toward the aso.No dilatation of coronary artery was observed compared to before the aso was implanted.The patient has been monitored.The author suggested that additional coil embolisation would be required if the coronary artery fistula become worse.The patient also has a risk of perforation due to vulnerable vessels.In order to carefully monitor signs of coronary artery fistula, a cag is likely to be needed after aso deployment.Doi: i-p04-01.

• 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: 6875221
• MDR Text Key: 86574830
• Report Number: 2135147-2017-00112
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 55