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

Catalog Number 9-PFO-3525

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

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 35-25mm amplatzer talisman pfo occluder was selected for implant on (b)(6) 2023 using a 9f amplatzer talisman delivery system to treat a large atrial septal defect associated to a patent foramen ovale.During implant the device took on a round shape.The device was removed from the patient and replaced with a new 40mm amplatzer multi-fenestrated septal occluder - cribriform.There were no interactions with cardiac structures nor were there any angulations or kinks noted in the delivery system.During device preparation, the device took on a round shape.The device was replaced with a new 40mm amplatzer multi-fenestrated septal occluder - cribriform, which was successfully implanted using a 10f amplatzer trevisio intravascular delivery system.There were no interactions with cardiac structures nor were there any angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was noted as fine with no patient consequences.

Manufacturer Narrative

An event of device deformity was reported.The device was returned to abbott for investigation and 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.Information from the field indicated that there was no anatomical interference or any angulation or kink in the delivery system upon deployment.Based on the information received, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.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: 18372469
• MDR Text Key: 331371171
• Report Number: 2135147-2023-05648
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8799110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2022
• 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
• Patient Age: 14 YR