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

Model Number 9600TFX29A

Device Problem Perivalvular Leak (1457)

Patient Problem Hemolysis (1886)

Event Date 12/20/2022

Event Type  Injury  

Event Description

As reported by implant patient registry, approximately 7 days post tavr procedure with a 29mm sapien 3 valve in the mitral position the patient had a valve in valve procedure due to unknown reasons.Another 29mm sapien 3 valve was implanted.Per medical records review and the fcs, the original procedure was an off label valve in mitral annular calcification.Mild paravalvular leak ws noted immediately post procedure, but as the echocardiographer looked closer, it appeared to be more moderate or severe.The patient experience hemolysis post procedure.The team decided they should implant a second valve more ventricular to help seal the leak.A second 29mm sapien 3 valve was implanted without significant improvement, so they used a vascular plug to seal the residual leak successfully.The pvl has improved, but the patient is still experiencing hemolysis.The team believes that the hemolysis likely had an underlying cause other than the valve.The pvl was due to the area of the mitral annulus inside of the patient's extensive calcium.It is close to 700mm2, which is larger than the 29mm valve they implanted.

Manufacturer Narrative

Thv/tvt registry.This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2023-10172.The investigation is ongoing.The device remains implanted.

Manufacturer Narrative

The device was not returned for evaluation.As the device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.The complaint for deployed valve exhibits paravalvular leak was confirmed based on medical records reviewed.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.In this case, thv-in-thv could not resolve the paravalvular leak as the pre-existing implanted valve (thv) had pre-existing paravalvular leak between the implanted valve (1st thv) and native mitral annulus.Per supplement training manual, assessment is recommended prior to mitral valve-in-valve implantation for any significant pre-existing paravalvular leakage.Implanting thv-in-thv at mitral position using the sapien 3 (s3) with the commander delivery system (ds) is not indicated for use.The risk management file captures risks for indicated device use only.Therefore, review of the risk management file is complete, and no further action is required at this time.As such, available information suggests that the procedural factors (pre-existing failure thv with paravalvular leak, off label) may have contributed to the reported complaint event.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.There were no ifu/training materials inadequacies or edwards defect identified.Therefore, no corrective or preventative actions or product risk assessment are required.

Manufacturer Narrative

The investigation is ongoing.

• Brand Name: EDWARDS SAPIEN 3 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: 16161298
• MDR Text Key: 307461387
• Report Number: 2015691-2023-10175
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)250829
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/12/2023; 03/10/2023
• Supplement Dates FDA Received: 02/06/2023; 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Female