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

Catalog Number 9-PFO-2518

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

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

Event Date 12/04/2023

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 25-18mm amplatzer talisman pfo occluder was selected for implant on (b)(6) 2023 using an 8f amplatzer talisman delivery sheath.During implant the right atrial disc took on a deformation in the intra-atrial septum.The device was removed from the patient and replaced with a new unknown device.There were no adverse effects to the patient.

Manufacturer Narrative

An event of the proximal disc of the device deforming during implant was reported.A returned device assessment could not be performed as the device was not returned for analysis.One image was received for examination, which appeared to show an occluder inside a patient during an implant procedure which had the proximal disc in a bulbous shape.Use of the incorrect size delivery system and anatomical interference are potential causes of the reported event.Information from the field indicated that the correct size delivery sheath was used and that there was interaction with cardiac structures during deployment, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.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: 18378999
• MDR Text Key: 331294133
• Report Number: 2135147-2023-05691
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/29/2024

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-2518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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