MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26

Device Problems Nonstandard Device (1420); Particulates (1451)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

As reported, during valve preparation of a 26mm sapien 3 ultra in aortic position, a strange substance on the leaflets of the valve was noted.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.Updated b5 and h6.Per follow-up, there was no particulate noted on the valve leaflet.The strange substance reported was leaflet tissue fibers.This was also confirmed through pre-decontamination evaluation.Small tissue fibers on the inflow of the rough surface of the valve are inherent to pericardial tissue.These fibers are embedded in the tissue and therefore the potential for injury is remote.Based on the new information, this event is no longer mdr reportable.

Event Description

Edwards received notification from our affiliate in belgium.As reported, this was an implant case of a 26mm sapien 3 ultra in aortic position by transfemoral approach.During device preparation, it was found a strange substance on the leaflets of the valve.It was not possible to remove the strange substance during rinsing.Through follow-up, it was learned that the reported strange residue was referring to tissue fibers of the leaflets.Another 26mm sapien 3 ultra valve was prepared to continue with the procedure and the final outcome was perfect.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18400938
• MDR Text Key: 331610561
• Report Number: 2015691-2023-18794
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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