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

Model Number 9750TFX26A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a tran-apical tmvr procedure with a 26mm sapien 3 ultra valve, the valve was implant too ventricular due to the patient having a 'tricky angle'.Paravalvular leak (pvl) and moderate central leak was noted, so the decision was made to implant a second valve.There was no pvl or central leak and no complications.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned for evaluation as it remains implanted.However, the instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 for malpositioned thv and deployed valve exhibits central regurgitation were unable to be confirmed due to unavailability of relevant procedural imagery or medical records.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.As reported, 'during a trans-apical tmvr valve in valve procedure with a 26mm sapien 3 ultra valve in a pre-existing surgical valve, the valve was implant too ventricular due to the patient having a 'tricky angle'.Paravalvular leak and moderate central leak was noted, so the decision was made to implant a second valve'.Valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.Per training manual, 'thv should be deployed around 70/30 to 80/20 (aortic/ventricular).' in this case, the valve was placed too ventricularly, which led to thv malposition during deployment.As such available information suggests that procedural factors (valve positioning) may have contributed to the complaint event.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.Thv malposition can result in improper leaflet function leading to central regurgitation.As such, available information suggests that procedural factors (valve malpositioned) may have contributed to the complaint event.However, a definitive root cause is unable to be determined.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: SAPIEN 3 ULTRA TRANSCATHETER HEART 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: 15999419
• MDR Text Key: 305680495
• Report Number: 2015691-2022-10079
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250719
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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