MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23

Device Problem Contamination (1120)

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

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our (b)(6), during preparation of a 23mm sapien 3 ultra valve, a black spot was noted on one of the valve leaflets after the second rinse was completed and the valve was released from the protective cage.The black spot could not be removed after vigorous rinsing or when touched lightly with a sterile gloved finger., a new sapien 3 ultra valve was used, and the valve was successfully deployed.Per report, the valve prep station is a separate working area and specifically kept clean and away from the scrub 'trolley', which can have plenty of blood present.The potential defect on the valve was noticed as soon as its protective white frame was removed.It appeared that the dot was within the valve itself.It was noted that the dot appeared to look different once the image was zoomed.The thread like tail was not originally visible.

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our (b)(4) affiliate, during preparation of a 23mm sapien 3 ultra valve, a black spot was noted on one of the valve leaflets after the second rinse was completed and the valve was released from the protective cage.The black spot could not be removed after vigorous rinsing or when touched lightly with a sterile gloved finger., a new sapien 3 ultra valve was used, and the valve was successfully deployed.Per report, the valve prep station is a separate working area and specifically kept clean and away from the scrub 'trolley', which can have plenty of blood present.The potential defect on the valve was noticed as soon as its protective white frame was removed.It appeared that the dot was within the valve itself.It was noted that the dot appeared to look different once the image was zoomed.The thread like tail was not originally visible.

Manufacturer Narrative

The 23mm sapien ultra valve was returned to edwards for evaluation.Visual inspection revealed the following: one (1) black fiber was observed on cp2 leaflet inflow side.Functional or dimensional testing performed as the evaluation is based on visual and material analysis.Material analysis was performed on the isolated material collected during product evaluation.Ftir results for the reported particulates show similar absorption characteristic when compared to cellulose like material.A review of manufacturing process was performed to determine if the particulate originated at edwards facility.A listing of all the tooling, fixtures and material used in the manufacturing line of 9750tfx valve were generated and reviewed.Based on the review, there was no similar material for cellulose used during manufacturing process.Additional review of all the tools/fixtures/workstations, indicated they were properly maintained in cleanroom during the walk-through.The operators were properly gowned with hair covers, shoe covers, and cleanroom gowns as observed during cleanroom review.There was no observation of non-conformance or abnormality.See manufacturing investigation report for manufacturing walkthrough.Therefore, it is not confirmed that the cellulose like material collected during evaluation originated from the thv manufacturing process at edwards singapore facility.During the manufacturing process, all inspections are conducted on 100% of the units.Device history record (dhr) review was performed and did not reveal any manufacturing non-conformance that would have contributed to the complaint event.A lot history record review was performed and did not reveal any related complaints.The commander delivery system with s3/s3u ifu and device preparation training manual was reviewed for instructions and guidance.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 was confirmed from the evaluation of the returned valve.A review of dhr, lot history, complaint history, and manufacturing mitigation 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 cellulose 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 cellulose 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.As reported, 'during the preparation, a black spot was noted on the valve leaflet.This was seen after the second rinse was completed and the valve was released from the protective cage.The black spot would not come away after vigorous rinsing or when touched lightly with a sterile gloved finger.As an action, a new sapien 3 ultra valve was used and successfully deployed.' it is possible that the black particulate was introduced during device preparation, as it was observed during the valve rinsing process.In this case, available information suggests that procedural factors (device prepping handling) may contributed to the complaint event.However, a conclusive 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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is 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 facility.Awareness communication is included as part of manufacturing investigation report.

• Brand Name: EDWARDS SAPIEN 3 ULTRA, 23MM
• 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: 13472317
• MDR Text Key: 285746126
• Report Number: 2015691-2022-03765
• 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: 04/12/2022

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: 05/28/2023
• Device Model Number: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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