MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-PFO-3025

Device Problems Difficult to Fold, Unfold or Collapse (1254); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6).2023, a 30-25mm amplatzer talisman pfo occluder was chosen for implant with an unknown delivery system.During device deployment in the left atrium, it was noticed the device had an odd shape.One of the device discs was deployed in the right atrium and was still noted to be misshaped.A decision was made to remove the device prior to release and replaced with a new unknown device.The removed device was inspected and found the waist of the device appeared deformed.The patient status was reported as stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of device deformity was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Per the instructions for use, the recommended size delivery system for use with a 3025mm talisman occluder is an 9f.A 10f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, however the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2023, a 30-25mm amplatzer talisman pfo occluder was chosen for implant with a 10f amplatzer trevisio intravascular delivery system.During device deployment in the left atrium, it was noticed the device had an odd shape.One of the device discs was deployed in the right atrium and was still noted to be misshaped.A decision was made to remove the device prior to release and replaced with a second 30-25mm amplatzer talisman pfo occluder.The removed device was inspected and found the waist of the device appeared kinked when compared to another device.There was no interaction with cardiac structures during deployment and no angulation or kink noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure due to this event other than what was required to prepare a second device.The patient status was reported as stable.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18369271
• MDR Text Key: 331073065
• Report Number: 2135147-2023-05632
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: 05415067033321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 8479115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female