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

Model Number 9750TFX26A

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The investigation is underway.

Event Description

As reported by a field clinical specialist, during the procedure of a 26 mm sapien 3 ultra valve in the aortic position via transfemoral approach, excessive force was needed to advance the delivery system with the crimped valve through the esheath.The patient had diffuse disease in the access vessels and a percutaneous transluminal angioplasty (pta) of the left common iliac was performed before the sheath was inserted.During deployment a bent strut on the valve frame was observed.The valve was deployed successfully.Upon removal of the esheath a "linear split was observed along the seam of the clear plastic section." the c-marker was still present.  no patient injuries were reported and the patient was discharged home.It is to be noted that per initial report, the damage to the valve frame appeared to be a "fracture"; however, upon initial review of procedural imagery provided (short video clip with cine images of valve deployment) no struts were observed to be separated from the valve frame.

Manufacturer Narrative

The product was not returned for evaluation.Imagery provided by the site revealed one valve strut was bent outward on the inflow side.The access vessel minimum luminal diameter was under 5.5mm and had severe tortuosity and calcification.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed other similar complaints.The sapien 3 ultra complaint history from may 2019 to april 2020 has been reviewed and similar complaints with engineering evaluation were found.Available information suggests that patient (access vessel tortuosity and calcification) and procedural factors (improper valve crimping, device maneuvering during delivery system advancement through sheath) may have contributed to the similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.Per the ifu it is to be noted, if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.If push force is too high or valve is still stuck, remove valve and sheath together as a single unit and replace.Do not over-manipulate the sheath at any time.During the manufacturing process, the device was visually inspected and tested several times.All sapien 3 ultra frame components are 100% visually inspection by both manufacturing and quality prior to final packaging.All inspections are conducted on 100% of units.These inspections and tests during the manufacturing process support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.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 frame damaged during use was confirmed based on the provided imagery.Due to the unavailability of a returned device (valve), no potential manufacturing non-conformance was able to be determined.A review of the lot history, dhr, manufacturing mitigations and complaint history did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.As noted and reported, ¿perceived root cause of insertion difficulty was tight vessel diameter with calcification and the patient had diffuse disease in the access vessels and a percutaneous transluminal angioplasty (pta) of the left common iliac was performed before the sheath was inserted.¿  additionally, the patient had access vessel mld under 5.5 mm as seen in the imagery reviewed.Per ifu and training manual precautions, the safety and effectiveness have not been established for patients with ¿access characteristics that would preclude safe placement of the edwards sheath, such as severe obstructive calcification or severe tortuosity,¿.The minimum required vessel diameter for a 14 fr sheath is 5.5 mm.  furthermore, reported that ¿excessive force was needed to advance the delivery system with the crimped valve through the esheath.¿ the presence of calcification, tortuosity and undersize vessel diameter can create a challenging pathway for delivery system insertion through the sheath and lead to resistance and high push force.With the excessive force applied, the valve could be damaged within the sheath.Per training manual, ¿if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system¿ and ¿do not over-manipulate the sheath at any time.¿  as such, available information suggests that patient factors (access vessel tortuosity/calcification/under sizing) and/or procedural factors (excessive device maneuvering during delivery system advancement through sheath) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.Due to the unavailability of the device, it cannot be determined if a manufacturing non-conformance contributed to the reported event.However, no edwards defect (design/manufacturing/labeling issue) was identified during the investigation.  a review of complaint history for the month of april 2020 revealed that the occurrence rate exceeded the control limit for the applicable trending category.  further review of these complaints found no device defect or manufacturing non-conformances.Since no edwards defects which could have resulted in the complaint were identified, no corrective and preventative action is required at this time.However, per management discretion, a product risk assessment was previously initiated to further investigate the issue.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10018357
• MDR Text Key: 194999240
• Report Number: 2015691-2020-11758
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2020

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: 12/05/2021
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 07/23/2020
• Supplement Dates FDA Received: 06/11/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR