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 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 after deployment the left atrial disc appeared to be "cobra" shaped.The device was recaptured and redeployed only to take on a cobra shape once again.The physician decided to remove the device.A new device was used to successfully complete the procedure.The patient remained stable.

Manufacturer Narrative

The reported event of the occluder deploying with a cobra deformation 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 and the product met all specifications.The cause of the reported event 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: 10942554
• MDR Text Key: 219564983
• Report Number: 2135147-2020-00521
• 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
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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: 7120329
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention