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

Model Number 9750TFX23

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during prep for a transfemoral tavr procedure, upon rinsing the valve in saline, a small black dot on one of the leaflets was observed and one of the leaflets appeared to be slightly thinner at the cusp.The valve was rinsed, and the particulate was attempted to be manually removed, however both efforts were unsuccessful.A new valve was opened and implanted.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

Section d10, h6 and h10: the valve was returned to edwards lifesciences for evaluation.The device underwent visual inspection and material analysis.During visual analysis, a black particulate (approx 0.0313¿ in length) was found on the cp3 leaflet.All three leaflets were reviewed for thin spots at 8x magnification and no visual abnormalities were observed.Material analysis was performed on the isolated material collected from the complaint site with fourier transform infrared spectroscopy (ftir).The ir spectrum of the unknown black particulate found on the leaflet could not be identified due to low match value (<50) when comparing to the spectral library.A review of manufacturing process was performed in order to determine if the black particulate could have originated at edwards singapore facility.A listing of all the tooling, fixtures and material used in the manufacturing line of 9750tfx valve were generated and reviewed.A listing of the relevant tools, fixtures and materials used during valve assembly were reviewed.Based on the review, all of the tools/fixtures/workstations were properly maintained in the cleanroom during the cleanroom walkthrough and there was no observation of non-conformance or abnormality.Furthermore, the material of the black particulate could not be identified even after ftir is performed as the match to the spectrum was low.As such, it is not confirmed that the black particulate collected during evaluation is originated from the thv manufacturing process for valve assembly at edwards singapore facility.A device history record (dhr) review performed did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review was performed and did not reveal any similar complaints.A review of complaint history from january 2019 ¿ december 2019 revealed no additional returned complaints for the sapien 3 ultra valve for the reported particulate, contamination or leaflet ¿ alleged irregular appearance ¿ during prep events.A review of complaint history reveals that the occurrence rate did not exceed the december 2019 control limits for these trend categories.The ultra valve with commander delivery system, instructions for use (ifu) and the device prepping manual were reviewed for instructions relating to the complaint.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are anticipated risks of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.The complaint for valve ¿ particulate, contamination was confirmed.The black particulate observed during visual evaluation was tested and the ir spectrum of the particulate cannot be identified due to low match value when comparing to the spectral library.Therefore, it is unknown if the particulate originated from edwards.Since the black particulate was found during device preparation (out of the jar), it is possible that the particulate originated from the field.There is insufficient information to determine a root cause at this time.Currently there are several manufacturing mitigations in place to detect and reject particulate on valve.Since no defects or labeling/ifu/training deficiencies were identified, no corrective or preventative actions are required at this time.However, an awareness communication emphasizing the importance of in-process mitigation on foreign particulate during manufacturing was performed as a precautionary measure.The complaint for leaflet ¿ alleged irregular appearance ¿ during prep was not confirmed.The tissue on all three leaflets were examined under 8x magnification and there were no visual abnormalities.Per the visual inspection procedure, the tissue was found to meet the acceptance criteria.No labeling/ifu deficiencies were identified during evaluation and a review of dhr and manufacturing mitigations also did not reveal any indications that a manufacturing nonconformance as a source of the complaint.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9440514
• MDR Text Key: 188707545
• Report Number: 2015691-2019-04564
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1