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

Model Number 9750TFX23

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

As reported by an edwards united kingdom affiliate, during device preparation with a 23mm sapien 3 ultra valve, there was a black particulate noticed.It was decided to not proceed with the valve.A new 23mm valve was opened and implanted successfully.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information.The device was returned to edwards lifesciences for evaluation, and visual inspected.Visual inspection showed one (1) black particulate on the outflow aspect of leaflet cp1, and it was approximately 2mm in length.The complaint event site provided imagery relevant to the complaint and the following observed: one (1) black particulate observed on the leaflet from inflow side.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for particulate noticed was confirmed based on the provided imagery and returned device evaluation.Per eds sem report, black particulate spectrum is consistent with iron-based alloy.Process walk through was performed by manufacturing to ensure none of the material, fixtures, or tooling used iron-based alloy.Additionally, during manufacturing process, all sapien 3 ultra valves are 100% visually inspected for particulate.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.A review of ifu/training materials revealed no deficiencies.As reported, 'during device prep for an implant of a 23mm sapien 3 ultra, on completion of the one minute/twice rinsing in saline, the green anchor suture was removed from the cage.On inspection of the valve, there was a black issue noticed'.It is possible that the particulate was introduced during device preparation due to the valve had been out of jar, and the particulate was observed after the valve rinsing.As such, available suggests that procedural factors (device prep handling) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: SAPIEN 3 ULTRA TRANSCATHETER HEART 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: 15829297
• MDR Text Key: 305880942
• Report Number: 2015691-2022-09364
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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