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

Model Number 9750TFX23

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Regurgitation (2259)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported, a 23mm sapien 3 ultra valve was implanted into a patient with an existing 25mm mitroflow valve.On pod1 through echo assessment, there were signs of one of the valve leaflets not coaptating causing transvalvular aortic regurgitation.The patient was hemodynamically stable.A non-edwards tavr valve was implanted.Patient is doing well and was discharged.

Manufacturer Narrative

The valve remains implanted; therefore could not be returned for evaluation.Imagery was provided by the complaint site and the following observations were made: only two (2) leaflets were able to be observed in the return imagery of the procedure possibly due to angle in which cine was taken.The color m-mode of the thv demonstrated flow in diastole which corresponds with valve regurgitation.A device history review (dhr) was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.  a lot history review did not reveal any other complaints related to the reported event.A review of complaint history for the sapien 3 ultra valve (all sizes) from august 2019 to july 2020 revealed no additional returned complaints for the reported events or equivalent codes.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.A review of complaint history reveals that the complaint occurrence rate did not exceed the july 2020 control limit for the trend categories.Instruction for use (ifu), patient screening manual, device prepping manual, and training manual for sapien 3 with commander delivery system were reviewed for instructions relating to the observed events.It should be noted that the thv was implanted into pre-existing bioprosthetic valve (25mm mitroflow) in aortic position for this case.The sapien 3 ultra (s3u) thv with the commander delivery system (ds) is indicated for native aortic valve replacement only in europe.The ifu in this section is for tf (transfemoral) procedure in the native aortic position and was reviewed for relevant guidance for an s3u implant using a commander delivery system.A review of the documents showed the following: indications: the edwards sapien 3 ultra system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery.During manufacturing, the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.The reported event of leaflet motion restriction was unable to be confirmed; however, the reported event of valve central regurgitation was confirmed based on the provided imagery.A review of the dhr, lot history and complaint history revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.It should be noted that the thv was implanted into pre-existing bioprosthetic valve (25mm mitroflow) in aortic position and the sapien 3 ultra thv with the commander delivery system (ds) is currently indicated for native aortic valve replacement only.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the  trans catheter aortic valve replacement (tavr) procedure.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the valve types, length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.The reported events could be potentially from multiple factors (i.E.Valve under expand, malposition and etc.).Due to insufficient information, a definitive root cause is 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.No product non-conformance was identified, and the occurrence rate did not exceed the trend category control limit, therefore a product risk assessment (pra) is not required.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10314267
• MDR Text Key: 200427118
• Report Number: 2015691-2020-12646
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 9750TFX23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR