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

Model Number 9-ASD-026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 26mm amplatzer septal occluder was implanted in a (b)(6) female.At the one month follow up, patient had an echocardiogram which demonstrated an erosion of the left atrial disc into the aortic root, which had created a small aortic - left atrial fistula.The right-sided disk was not involved.There was no effusion was observed and the patient was asymptomatic.The patient was brought to the or where through a hockey stick aortotomy (top of the sinotubular junction at the level of the noncoronary sinus) one could visualize the aortic valve was normal.One could see the metal from the left disk of the amplatzer device through a hole in the noncoronary sinus of the aorta.This defect was closer to the non-left commissure.The device was now able to be removed carefully without tearing of tissue.No sharp dissection was necessary.The asd was large.The defect was closed in the roof of the left atrium with a piece of cardiocel bovine pericardium.The defect in the aorta was closed with three horizontal mattress sutures of 5-0 prolene backed with autologous pericardium.The aortic valve was unperturbed.The large asd was closed with a piece of cardiocel bovine pericardium.The patient is reported to be recovering well from the procedure and discharged on (b)(6) 2018.

Manufacturer Narrative

The device was returned due to erosion.The returned 26 mm amplatzer septal occluder met all functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported erosion remains unknown.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7879559
• MDR Text Key: 120382064
• Report Number: 2135147-2018-00150
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• 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: 09/21/2018

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: 08/31/2021
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5648574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 08/19/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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: 26 YR
• Patient Weight: 57