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

Model Number 9600TFX26J

Device Problems Particulates (1451); Contamination /Decontamination Problem (2895)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), during preparation for a transfemoral transcatheter aortic valve replacement in the native aortic position, an operator found a black speck on the valve leaflet of the inflow side.It could not be removed by rinsing, and a new valve was used for the procedure.There was no report of any injury to the patient.

Manufacturer Narrative

The following report fields have been updated due to additional information received: g3, h6.The edwards sapien 3 valve (9600tfx) was returned for evaluation.The returned device was visually inspected for any abnormalities and the following was observed: one (1) black particulate approximately 1mm in length found on cp1 leaflet near c2 commissure.Black particulate on cp1 leaflet a device history review (dhr) of the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review of a work order was performed and revealed no other complaints relating to the complaint codes.During manufacturing, the device was 100% inspected.During the final inspection, the device underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.These inspections and tests performed during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The instructions for use (ifu) for the commander delivery system with sapien 3 transcatheter heart valve ( thv, japan) and device preparation training manual were reviewed.Per the warnings/cautions: do not use the valve if the tamper evident seal is broken, the storage solution does not completely cover the valve, the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed.Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.G., kinked or stretched), or the expiration date has elapsed.Before opening the valve jar, carefully examine for evidence of damage (e.G., a cracked jar or lid, leakage, or broken or missing seals).Carefully remove the valve/holder assembly from the jar without touching the tissue.Rinse the valve as follows: place the valve in the first bowl of sterile, physiological saline.Be sure the saline solution completely covers the valve and holder.With the valve and holder submerged, slowly agitate (to gently swirl the valve and holder) back and forth for a minimum of 1 minute.Transfer the valve and holder to the second rinsing bowl of sterile physiological saline and gently agitate for at least one more minute.Ensure the rinse solution in the first bowl is not used.The valve should be left in the final rinse solution until needed to prevent the tissue from drying.Do not allow the valve to come into contact with the bottom or sides of the rinse bowl during agitation or swirling in the rinse solution.Direct contact between the identification tag and valve is also to be avoided during the rinse procedure.No other objects should be placed in the rinse bowls.The valve should be kept hydrated to prevent the tissue from drying.A risk assessment was performed on the reported event and revealed no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, no corrective actions preventive actions (capa) or product risk assessment (pra) escalation is not required.There is no confirmation that the black particulate originated from edwards.However, as precautionary measures, an awareness communication emphasizing the importance of in-process mitigation on foreign particulate during manufacturing was performed in edwards singapore facility.The complaint for "device preparation - particulate - noticed" 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 particulate showed similar absorption to polyurethane/abs blend 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 black polyurethane/ abs bend 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, "during preparation for a transfemoral transcatheter aortic valve replacement (tavr) for the native aortic position, an operator found a black speck on a leaflet of the inflow side.As it could not be removed by rinsing, a new valve was used for the procedure".It is possible that the particulate was introduced during device preparation, as they were observed during the valve rinsing process.However, a definitive root cause is unable to be determined at this time.The complaint for "device preparation - particulate - noticed" was confirmed.Based on the dhr, lot history, complaint history review and the listing of tooling, fixture, and material for the manufacturing of 9600tfx, it is concluded that the black particulate was unlikely to be a manufacturing non-conformance was unlikely to be a manufacturing non-conformance as no black polyurethane/abs blend like material are being used in the manufacturing of 9600tfx.Currently, there are several manufacturing mitigations in place to detect and reject particulate and/ fiber on valve.Available information suggests that procedural factors (device mishandling during prep) may contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.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.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 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: 12426161
• MDR Text Key: 270365941
• Report Number: 2015691-2021-05034
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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: 11/13/2022
• Device Model Number: 9600TFX26J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/04/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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