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

Model Number 9-ASD-014

Device Problem Material Deformation (2976)

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

Event Date 10/05/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 14mm amplatzer septal occluder deployed deformed during the procedure.The device was removed, and outside the patient the disc continued to deploy deformed.A 25mm amplatzer pfo occluder was successfully implanted using the same 9f amplatzer torqvue delivery system.The procedure was not extended beyond 20 minutes and the patient remained hemodynamically stable throughout.The user suggested the event was due to a device malfunction and not patient anatomy.The patient is reported to be discharged.

Manufacturer Narrative

The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Per the instructions for use artmt100116885 ver.A, the recommended delivery system size for a 14mm amplatzer septal occluder is a 7f.

• 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: 8050904
• MDR Text Key: 126529186
• Report Number: 2135147-2018-00207
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: 00811806010113
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 6206224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• 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?: Yes
• Date Device Manufactured: 11/13/2017
• 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