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

Model Number 9-ASD-010

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event of an amplatzer septal occluder deploying with a cobra deformation could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, three photos were received for analysis.Based solely on the aforementioned photos, the occluder appeared to be deformed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 10mm amplatzer septal occluder was selected for implant in the patient.During the procedure, the device deployed in a cobra headed shape.The physician removed the device from the patient and a new amplatzer septal occluder was implanted without any issues or implications to the patient's condition.The patient remained hemodynamically stable throughout the procedure, there were no patient injuries and there was no clinically significant delay in the procedure.

Manufacturer Narrative

The reported event of device deformation could not be confirmed.Three photos were received from the field, which appeared to show a deformed occluder.However, the investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10730548
• MDR Text Key: 213034432
• Report Number: 2135147-2020-00455
• 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,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 7037606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1