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

Catalog Number 9-PFO-2518

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that a 25-18mm amplatzer talisman pfo occluder was selected for implant on (b)(6)2024 using a 9f amplatzer trevisio intravascular delivery system.During implant the right atrial disc of the device took on a bulbous shape.It was noted that the bulbous shape decreased slightly when the physician attempted the push and pull test whilst leaning the disc against the loader.Ice was reviewed and it was noted that there was zero flow around or through the device.The right disc still maintained a less-bulbous shape but did not return to its original shape.The physician released the device from the delivery system.There were no interactions with cardiac structures.There were no angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout 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 a device deforming during implantation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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, however is consistent with use of larger sheath, as use of a larger sheath may influence deformations of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the instructions for use, the minimum recommended size delivery system for use with a 25-18mm amplatzer talisman pfo occluder is an 8f.

• 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: 18686300
• MDR Text Key: 335185950
• Report Number: 2135147-2024-00611
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 9158364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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
• Treatment: 9F AMPL TREV DS [9-ATV09F45/80, LOT: 8840438]
• Patient Age: 24 YR