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

Model Number 9-ASD-024

Device Problem Unintended Movement (3026)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since the lot number is unknown.An event of "device 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 information was obtained from the following literature article: kim hh.Et al, "late migration of amplatzer septal occluder device to the descending thoracic aorta." korean j thorac cardiovasc surg.2017 feb;50(1):47-49.A (b)(6) male patient underwent transcatheter closure using a 24 mm amplatzer septal occluder (aso) guided by transesophageal echocardiography (tee).The patient was discharged after 3 days of hospitalization.The proper position of the aso was confirmed by transthoracic echocardiography (tte) on the day of discharge.There were no immediate postoperative complications.At a routine follow-up visit, a year after implantation, the diagnosis of device migration was made based on a chest computed tomography (ct) scan and echocardiography.The chest ct scan showed the presence of the aso in the descending thoracic aorta at the level of t6¿t7.Tee showed no interruption in aortic blood flow between the device and the aortic lumen.The patient had no symptoms, such as chest discomfort or dyspnea, associated with asd occluder migration.Physical examination revealed no abnormal findings.Because of the risk of aortic plugging or perforation, the patient was referred to the operating room.A patch repair of the asd was carried out using a bovine pericardial patch and the aso was removed.Pathological examination of the aso showed that structural integrity was maintained without distortion.There were no perioperative or postoperative complications.Patient identifier and weight are 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: 7135824
• MDR Text Key: 95451467
• Report Number: 2135147-2017-00186
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• 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: 65 YR