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

Model Number 9-ASD-016

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

An event of embolization was reported.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

The article titled, successful percutaneous retrieval of embolized septal occluder device from aortic arch and placement of a newer septal occluder device in combined procedure (case rep cardiol.2016;2016:1032801), presented a unique case of percutaneous retrieval of an embolized amplatzer septal occluder (aso) and placement of newer larger aso in a single procedure.A (b)(6) -year-old female patient with history of persistent atrial fibrillation after multiple failed cardioversions and septum secundum type of atrial septal defect (asd) presented with worsening exertional dyspnea of six-month duration.She underwent elective catheter based atrial fibrillation ablation followed by closure of the asd during a combined percutaneous procedure.Asd closure was performed using a 16 mm aso after measuring the diameter of the defect at 15.4 ± 1.0 mm with sizing balloon and 15 mm with intracardiac echocardiogram (ice).After the deployment of the device, ice showed minimal residual shunt flow confirming correct position.The following day, a transthoracic echocardiogram (tte) revealed severe right to left shunt indicating recurrence of the asd, without visualization of the aso.A chest radiograph showed the embolized aso in the aortic arch.The patient had no new symptoms except recurrence of atrial fibrillation requiring cardioversion.The patient was taken to the cardiac catheterization laboratory for possible percutaneous retrieval of the embolized aso and placement of a newer device.Using a 6f en-snare system through a 6f hockey stick ii guiding catheter, the metallic tip on the right atrial disc of aso was snared.Subsequently, entire device was collapsed into the long sheath which was safely removed.Thereafter, a 20 mm aso was placed using a 9f amplatzer torque 45 delivery system, after resizing of the defect.This time the sizing balloon yielded a diameter of 17.41 mm and ice of 18 mm.Both ice and tte showed a properly positioned aso with minimal residual shunt.No procedure related complications occurred.The patient was discharged two days later.

• 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: 7120219
• MDR Text Key: 94932662
• Report Number: 2135147-2017-00169
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/14/2017
• 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: 75 YR