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

Model Number 9600TFX26A

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

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

Event Date 06/11/2020

Event Type  malfunction  

Event Description

26mm sapien 3 valve, commander ds, esheath as reported by the clinical specialist, during preparation for a tf tavr case, blue lint was observed on the inside of one of the leaflets.The fcs was able to remove it with difficulty and felt fine micro threads pulling at the leaflet.Visually it seemed to be removed but the team felt there might be additional material.The physician was uncomfortable implanting the valve and a second valve was opened and implanted without issue.Per the fcs, the blue material was on the underside of the leaflet and was not observed until it was being checked carefully before crimping, after the rinsing.

Manufacturer Narrative

The valve was returned uncrimped in a jar with solution, the holder, and a piece of telfa and serial tag.A blue particulate was observed on the telfa(white sponges).Multiple blue fibers were attached to the leaflet at the inflow of the valve.Material analysis was performed on the isolated material collected during product evaluation with fourier transform spectroscopy (ftir).The ftir results for the blue particulates indicated that they displayed similar absorption characteristics to ¿cellulose¿ virgin bleached chemical pulp fiber.A dhr review was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the event.A lot history review did not reveal any other similar complaints for the same work order.A review of complaint history on confirmed device complaints from july 2019 through june 2020 revealed other complaints for the sapien 3 valve for ¿valve ¿ particulate, contamination¿.Only one other complaint was also found to be related to blue cellulose particulate contamination.As blue surgical towels were used in this case and particulate was found during device preparation, the source of contamination could have originated from the field due to cross contamination.The ifu and device prepping manual were reviewed for instructions relating to the complaint.The operator is instructed to 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.The valve should not 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.During manufacturing of the sapien 3 valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The complaint for ¿valve ¿ particulate, contamination¿ was confirmed.Material analysis was performed on the blue particulates/fibers and the sample spectrum of the blue particulates/fibers are consistent to cellulose like material.However, a review of the dhr, lot history and complaint history revealed no indication that a manufacturing nonconformance contributed to the complaint.Process walkthrough was performed by manufacturing to ensure none of the materials, fixtures or tooling used matches blue cellulose like material and there were no matches observed.Additionally, during the manufacturing process, all sapien 3 valves are 100% visually inspected for defects.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.No labeling/ifu deficiencies were identified during evaluation.As reported, ¿the blue material was on the underside of the leaflet and was not observed until it was being checked carefully before crimping, after the rinsing¿.In addition, it was noted that blue or towels were used at site.Linting from surgical towels are common due to the nature of the product (made with cotton ¿ cellulose material).The lint fibers can carry through the air and transfer to other adjacent area.In this case, thv had been opened and inside the rinsing bowl, therefore it was possible that the particulates/fibers were introduced or cross contaminated during device prepping process.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.No manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.However, awareness communication (valve inspection and handling) was performed as a cautionary response.No product non-conformance was identified, therefore a product risk assessment is not required.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10228430
• MDR Text Key: 198488215
• Report Number: 2015691-2020-12416
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2021
• Device Model Number: 9600TFX26A
• Device Lot Number: 7123780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1