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

Catalog Number 9-PFO-3025

Device Problems Patient Device Interaction Problem (4001); Separation Problem (4043)

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

Event Date 12/11/2023

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 30-25mm amplatzer talisman pfo occluder was selected for implant on (b)(6) 2023.The device was prepared properly per ifu.During implant it was observed that when attempting to turn the cable, the cable would not turn on the screw.The device was unable to be released.The device was removed from the patient.Outside of the patient, it was noted that there was tissue on the cable.There was no suspected tissue damage.The device was replaced with a new 30mm amplatzer multi-fenestrated septal occluder - cribriform.The patient status was stable.

Manufacturer Narrative

An event of patient device interaction problem and separation problem were reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The reported separation problem was unable to confirm.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from field indicated that during the procedure, the cable would not turn on the screw and unable to be released the occluder.Therefore, the occluder was removed and a new occluder was used.There was tissue on the cable and there was no suspected tissue damage.Additional, a photo was provided and the occluder was attached to the cable.Based on the information received and returned device analysis, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18436788
• MDR Text Key: 331810453
• Report Number: 2135147-2024-00021
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: 05415067033321
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/03/2024
• 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: 8924101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2023
• 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
• Patient Age: 27 YR
• Patient Sex: Male