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

Model Number 9-ASD-010

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/16/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, a 10 mm amplatzer septal occluder was chosen for the procedure.Post deployment of the device, the left atrial disc came out in cobra shape.It was then pulled in again and out of the patient it stayed in cobra shape.The device was replaced and the second one was placed perfect.No patient consequences to report.

Manufacturer Narrative

The manufacturing report number for the initial is incorrect.The manufacturing site has the manufacturing report number 2135147.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; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442
• MDR Report Key: 9571001
• MDR Text Key: 174784488
• Report Number: 3008452825-2020-00010
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010076
• UDI-Public: 00811806010076
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 6429230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1