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

Model Number 9-ASD-028

Device Problem Unintended Movement (3026)

Patient Problem Arrhythmia (1721)

Event Date 12/06/2018

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.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 28mm amplatzer septal occluder was selected after sizing the defect per the ifu.At an unreported point in time, the patient had previously received a 30mm gore device that had embolized to the ascending aorta and remained in situ.The amplatzer septal occluder was positioned and released, remaining stable after the procedure.On (b)(6) 2018, echocardiogram showed the device had embolized to the left ventricle and the patient presented symptoms of slight ectopy, otherwise asymptomatic.The patient was taken to surgery where both the gore and amplatzer devices were removed, and the asd was closed surgically.The patient is reported to be stable and no negative patient outcomes were reported.

• 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: 8239474
• MDR Text Key: 132779209
• Report Number: 2135147-2019-00016
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: 00811806010212
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 6265497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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