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

Model Number 9600TFX29

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/15/2022

Event Type  malfunction  

Event Description

As reported by an edwards united kingdom affiliate, during preparation for a transfemoral tavr procedure with a 29mm sapien 3 valve, a green thread was seen embedded into one of the leaflets while rinsing the valve.A new valve was opened and implanted successfully.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information.The returned device was visually inspected for any abnormalities and the following was observed: one (1) blue fiber, approximately 8mm in length was observed on cp2 leaflet inflow side.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 from the evaluation of the returned valve.A review of device history report (dhr), lot history, complaint history, and manufacturing mitigations did not provide any indications that a manufacturing non conformance would have contributed to the complaint.Per material analysis results, the blue particulates showed similar absorption to poly (ethylene) material.Process walk through was performed by manufacturing.Process walk through was performed by manufacturing to ensure none of the material, fixtures, or tooling used match blue poly (ethelene) material.Additionally, during manufacturing process, all sapien 3 valves are 100% visually inspected for particulate.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.No labeling/ ifu deficiencies were identified during evaluation.As reported, 'it was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve in aortic position by transfemoral.During device preparation, while rinsing the valve, a green thread was seen embedded into one of the leaflets.The particle was seen embedded in the valve after rinsing'.It is possible that the blue particulate (reported as green thread) was introduced during device preparation, as it was observed during the valve rinsing process.As such, available information suggests that procedural factors (device prepping handling) may contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, 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: EDWARDS SAPIEN 3 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: 13742781
• MDR Text Key: 296164886
• Report Number: 2015691-2022-04396
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2021
• 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