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

Catalog Number 9-PFO-3025

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that a 30-25mm amplatzer talisman pfo occluder was selected for implant on (b)(6)2023 using a 9f amplatzer talisman delivery system.During implant the device took on a bulbous shape.The device was removed from the patient and replaced with a new 30-25mm amplatzer talisman pfo occluder.There were no interactions with cardiac structures nor were there any angulations or kinks in the delivery system.The patient remained hemodynamically stable during the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.

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.A returned device assessment could not be performed as the device was not returned for analysis.Image received from the field appeared to show the device in bulbous formation inside the patient.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.Na.

• 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: 18243298
• MDR Text Key: 329889678
• Report Number: 2135147-2023-05273
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: 05415067033321
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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 Catalogue Number: 9-PFO-3025
• Device Lot Number: 8703324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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