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

Model Number 9-ASD-010

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of deformity upon deployment could not be confirmed.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

The left atrial disc of a 10mm amplatzer septal occluder (aso) deformed cobra-shaped upon deployment despite multiple attempts.The aso was removed and replaced with a second 10 mm aso.There were no consequences for the patient and the patient remained hemodynamically stable throughout the procedure.The procedure was not significantly extended: 30 minutes due to this event, and the user does not attribute the deformation to patient anatomy.The patient has been discharged.

• 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: 8053125
• MDR Text Key: 126600265
• Report Number: 2135147-2018-00208
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010076
• UDI-Public: 00811806010076
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/08/2018

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: 12/31/2020
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 5347001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• 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): Required Intervention