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

Model Number 9-ASD-016

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

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

The reported event of aorta¿to¿right atrium fistula could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A literature article titled, transcatheter closure of aorta-to-right atrium fistula caused by erosion of amplatzer septal occluder (jacc cardiovasc interv.2017 feb 27;10(4):e33-e35), reviewed a case of a (b)(6) girl with a 12mm secundum-type atiral septal defect (asd) and a deficient aortic rim underwent successful asd closure using a 16mm amplatzer septal occluder (aso).Follow-up echocardiography 1 month later showed a small aorta¿to¿right atrium fistula.The patient was asymptomatic initially but developed hematuria and fatigue 3 weeks later.Hemoglobin dropped to 9.8 g/dl from 13.4 g/dl.After informed consent was obtained from the patient¿s parents, cardiac catheterization was performed under general anesthesia with fluoroscopic and transthoracic echocardiographic guidance.Aortography showed that the diameter of the fistula was 3 mm.The fistula was crossed in a retrograde fashion from the aorta using a 5-f judkins right coronary catheter.A 0.035-inch glide wire was advanced into the superior vena cava and exteriorized out of the femoral vein.A 6-f patent ductus arteriosus delivery sheath was advanced in an antegrade manner into the ascending aorta.A 6/4mm patent ductus arteriosus device was deployed to close the fistula.The patient is doing well with good device position and no residual leak on echocardiography through 3-year follow-up.Patient weight is not available.

• 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: 7120210
• MDR Text Key: 94928608
• Report Number: 2135147-2017-00166
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• 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: 7 YR