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

Model Number 9-ASD-030

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 11/27/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, after sizing the atrial septal defect using a 34mm sizing balloon and measuring the defect to 26mm, a 30mm amplatzer septal occluder was selected for implant.After deploying the device, a push-pull test was performed to confirm device stability and appeared to be well seated, observed on echocardiogram and angiogram.Then the device was released from the delivery cable and implanted.Following the procedure, while still in the hospital, the device was observed to have embolized to the right ventricle.The physician elected not to attempt snare or other percutaneous removal of the device as patient anatomy didn't allow for a larger device to close the defect.On (b)(6) 2018, the patient was transferred to another hospital where the device was surgically removed and the asd was patched successfully.Post-operatively, the patient is reported to be recovering.The user comments that the device embolized due to insufficient posterior rim tissue to hold the device in place and not related to the device.

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.Information from the field indicated that the device embolized due to insufficient posterior rim tissue to hold the device in place and not related to the device.

• 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: 8177285
• MDR Text Key: 130909756
• Report Number: 2135147-2018-00242
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: 00811806010229
• 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: 01/14/2019

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 Expiration Date: 07/31/2022
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 6092081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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