MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-014

Device Problem Unintended Movement (3026)

Patient Problem Blood Loss (2597)

Event Date 11/16/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 14mm amplatzer septal occluder was implanted.At the end of procedure, blood was noticed in the endotracheal breathing tube; however, once the bleeding resolved the patient was extubated successfully.Post-procedure ct scan showed the device had embolized to the abdominal aorta.On (b)(6) 2018, the occluder was snared through the femoral artery without any complications.The patient is scheduled for percutaneous closure of the asd on (b)(6) 2018.The patient is reported to be stable.

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 14mm amplatzer septal occluder was implanted.At the end of procedure, blood was noticed in the endotracheal breathing tube; however, once the bleeding resolved the patient was extubated successfully.Post-procedure ct scan showed the device had embolized to the abdominal aorta.On (b)(6) 2018, the occluder was snared through the femoral artery without any complications.The patient was scheduled for percutaneous closure of the asd on a later date.The patient is reported to be stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8139108
• MDR Text Key: 129515205
• Report Number: 2135147-2018-00233
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019226
• UDI-Public: 05415067019226
• 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,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 5616978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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: 61 YR