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

Model Number 9600TFX26A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Incomplete Coaptation (2507); Failure to Align (2522); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problems Aortic Regurgitation (1716); No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of two manufacturer reports being submitted for this case.   investigation is ongoing.

Event Description

As reported, during a transfemoral tavr with a 26mm s3 valve in the aortic position, one of the valve leaflet was stuck and central leak was noted.  the second valve was prepped and difficulty with valve alignment on the balloon was noted.  it was decided to retrieve the valve back into the sheath but was unsuccessful due to the valve struts being bent on the proximal end.  the device was unable to be withdrawn and a cut down was performed to remove the system.  the patient is doing well.  this was a known difficult case in which the patient¿s anatomy (heavily calcified and tortuous) most likely contributed to the difficulties.  the patient is planned for an intervention to repair the leak in the near future.

Manufacturer Narrative

Corrections to section b1.Please reference related manufacturer report no: 2015691-2019-03261 the valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.  in addition, no relevant imagery was provided for review.  due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.During the manufacturing, the sapien 3 valve frame components were 100% visually inspected for defects.  leaflet components were 100% tested.  during the production flow testing, the coaptation test was performed valves were 100% visually inspected before and after being attached to holder.  in addition, prior to final packaging, 100% visual inspection was performed on the valves.  these manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the complaint.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a review of the complaint history from september 2018 to august 2019 revealed one additional similar complaints with device return; however, no manufacturing non-conformances were identified during the similar complaint evaluation.  available information suggested that procedural factors may have caused or contributed to the event.A review of complaint history revealed that the occurrence rate did not exceed the control limit for the applicable trend categories.A review of the instruction for use (ifu) and training manuals for revealed no deficiencies.  per the ifu: anatomy (stj, calcification, coronaries, etc.), % area sizing, thv size and foreshortening / inflation volume should also be considered when initially positioning the thv; withdraw the delivery system from the thv before assessing; perform an aortogram with wire still in the lv to assess: thv position and complete expansion, functional assessment of thv (ar, pvl, etc.), annular and aortic integrity.Typically final deployed thv position will be around 70/30 to 80/20 (aortic/ventricular) when using optimal initial thv positioning where the center markers is within the optimal initial center marker zone.A review of the risk management documentation was performed and 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 complaints for leaflet motion restricted in patient and valve central leak were unable to be confirmed.A review of the dhr, revealed no indication that a manufacturing non-conformance contributed to the complaint.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.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.There are multiple patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or nonfunctioning leaflet.Based on historical review of complaints, these events are typically a result of native leaflet overhang due to valve deployment too ventricular, leaflet impingement due to the guidewire, leaflet impingement in a calcified valve, over inflation of the deployment balloon, underexpanded an oversized valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Per the ifu, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and transcatheter heart valve replacement procedure.The aforementioned patient/procedural factors can all contribute to suboptimal coaptation of the leaflets and cause central aortic regurgitation.In this case, no relevant imagery was provided for evaluation, and information related to native valve measurement, final valve position (a/v ratio), inflation volume and native valve calcification were unknown.There is insufficient information to determine a definitive root cause at this time.Since no product non-conformances or labeling/ifu/training deficiencies were identified, and the occurrence rates did not exceed the applicable trend categories control limits, a product risk assessment (pra) escalation, preventative or corrective actions (capa) are not required.

Manufacturer Narrative

Additional information received from implant patient registry¿s obituary search that the patient expired 2 days post tavr procedure.  the cause of death is unknown at this time.

Manufacturer Narrative

Additional information received from the physician stated that the cause of death was due to a retroperitoneal bleed.  the death is captured in related manufacturer report no: 2015691-2019-03261.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 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: 8951655
• MDR Text Key: 157039754
• Report Number: 2015691-2019-03259
• 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,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 02/05/2020; 03/18/2020; 07/23/2020
• Supplement Dates FDA Received: 11/04/2019; 03/03/2020; 03/25/2020; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention