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

Model Number 9600TFX29

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Event Description

Edwards received notification from our affiliate in italy.As reported, this was a valve-in-valve (viv) case of an implant of a 29mm sapien 3 transcatheter heart valve in a non-edwards valve, in mitral position.The patient was underwent general anesthesia, sternotomy, initiation of extracorporeal circulation, and cardioplegic arrest.During the procedure, the 29mm sapien 3 valve was implanted in the mitral position.During the closure of the atrium and declamping of the aorta, transesophageal control found that there was moderate to severe paravalvular leak and the implant position was too atrial.It was decided to clamp the aorta, open the atrium again and explant the 29mm sapien 3 valve that was just implanted.A second 29mm sapien 3 kit was prepared.The second 29mm sapien 3 valve was implanted more ventricularly this time.The atrium was closed and the aorta declamped.At this time, the transesophageal control did not show any leak.The patient was transferred to icu.As per medical opinion, the root cause of the event might be related to the fact that the valve was not correctly positioned in the pre-existing prosthetic valve.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.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 complaints of valve malposition and paravalvular leak were unable to be confirmed due to unavailability of applicable imagery/medical report.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Therefore, no device history record or lot history are required.A review of ifu/training materials revealed no deficiencies.Per the event description, ''during procedure, the 29mm sapien 3 valve was implant in mitral position, and it was proceed with the closure of the atrium and declamping of the aorta.But, in the transesophageal control, it was found that there was moderate/severe paravalvular leak and the implant position was too atrial.As per medical opinion, the root cause of the event might be related to the fact that the valve was not correctly positioned in the pre-existing prosthetic valve.'' additionally, per the review of the complaint activities, ''there was no positioning problem.The only problem was that the physician didn't consider the fact that the sapien shortens during inflation and so the crimped valve was not positioned correctly.'' per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement procedure.Per the training manual, ''final sapien 3 valve implant depth should be targeted no more than 20% (atrial) for optimal valve function.'' in addition, as epic valve is a stented surgical valve, during valve positioning, the base of the central marker should be aligned 3-5mm below the base of the existing surgical valve stent frame per the training manual.In this case, the thv was positioned incorrectly, which caused the thv to land too atrial upon deployment.As such, available information suggests that procedural factors (valve positioning technique) may have contributed to the complaint event.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted and the cardiac tissue due to a lack of appropriate sealing of the valve to the target site.In this case, the thv was implanted too atrial or malpositioned, so the pvl skirt was likely unable to properly seal against the target site (pre-exisiting bioprosthetic valve), resulting in paravalvular leak.As such, available information suggests that procedural factors (malpositioned thv) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/product risk assessment (pra)) is required.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16225219
• MDR Text Key: 307915814
• Report Number: 2015691-2023-10316
• Device Sequence Number: 1
• Product Code: NPU
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male