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

Model Number 9-ASD-016

Device Problem Material Deformation (2976)

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

Event Date 10/19/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder was selected for implant.During positioning, the device deployed deformed.The device was removed from the patient and continued to deploy deformed, as well as maintaining its mis-shaped appearance.The device was exchanged for another.

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder was selected for implant.During positioning, the device deployed deformed, taking the shape of a vsd occluder.The device was removed from the patient and continued to deploy deformed, as well as maintaining its mis-shaped appearance.The device was exchanged for an 18mm amplatzer septal occluder (lot number: 6483539).There were no patient consequences and the procedure was not significantly extended.

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.

• 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: 8051504
• MDR Text Key: 126550458
• Report Number: 2135147-2018-00206
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/21/2019

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: 02/28/2021
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 5414030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/06/2018; 01/10/2019
• Supplement Dates FDA Received: 12/08/2018; 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention