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

Model Number 9-ASD-016

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 16mm amplatzer septal occluder was selected for implant.During the deployment, the device did not fully deploy into a flat disk.The device was recaptured and redeployed several times, but the left atrial disk still formed a bulbous shape.The device was removed and exchanged for another 16mm asd, which was successfully implanted in the patient.

Manufacturer Narrative

The reported event of device deformation could not be confirmed.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.Please note, per the instructions for use, (b)(4) revision a "warnings: do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if the device interferes with any adjacent cardiac structure, such as superior vena cava (svc), pulmonary vein (pv), mitral valve (mv), coronary sinus (cs) or aorta (ao).Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device.".

• 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: 10596969
• MDR Text Key: 208951972
• Report Number: 2135147-2020-00414
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 6094269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1