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

Model Number 9750TFX23

Device Problem Nonstandard Device (1420)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in the (b)(4), during preparation of a 23mm sapien 3 ultra valve, the valve was washed but it had some dark material on one of the leaflets.The valve was not used.Another valve was successfully implanted in the patient with a good result.

Manufacturer Narrative

The valve was returned unused, detach from holder, without serial number tag.One black particulate approximately 0.03" in size was observed on inflow aspect of leaflet.The complaint for particulate was confirmed from the evaluation of the returned valve.A review of 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 ftir material analysis results, the black particulates showed similar absorption to urethane alkyd, (linseed oil-rich) 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 urethane alkyd, (linseed oil-rich) material.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.No labeling/ ifu deficiencies were identified during evaluation.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.As reported, "a new 23mm sapien 3 ultra valve was taken and washed but it also had some dark material on one of the leaflets".It is possible that the black particulate 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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14135980
• MDR Text Key: 289464168
• Report Number: 2015691-2022-05205
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Female