MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN M3 VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9880TFX29MCLUS

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2022

Event Type  Injury  

Event Description

As reported by the encircle clinical study.Approximately 30 days post successful tmvr, during the patient's follow up visit tee, severe stenosis with a mean gradient of 11mmhg was noted.Per the records received, the mitral bioprosthetic valve was well-seated.Mild transvalvular regurgitation was observed.

Manufacturer Narrative

The complaint device, sapien m3 valve - model 9880tfx29mclus, is not sold or marketed in the us; however, it is deemed similar to the sapien 3 transcatheter heart valve - model 9600tfx29, pma # p140031.The pma/510k field will be blank.Investigation is ongoing.Valve remains implanted.

Manufacturer Narrative

Update to b4, g3, g6, h2, h6 and h10 to reflect no product return investigation and medical records received.The device was not returned for evaluation as it remains implanted in the patient.As no device was returned, no visual inspection, functional testing or dimensional testing could be performed.Procedural imagery was reviewed.Per imagery, the valve waist was present after initial valve deployment, and the valve was still present after post-dilation.Post-procedure imagery was reviewed by echo core labs.Per the assessment made, the post-procedure (tte, pod-1) showed, transmitral antegrade peak gradient was 14.4 mmhg, transmitral antegrade mean gradient was 8.1 mmhg, transmitral antegrade cw doppler vti was 43.2 cm.Post-procedure (tte, pod-30) indicated hyperchogenic mass in la seems to be artifact.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed using the valve serial numbers from the related work order was performed and revealed two complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.A complaint history review on confirmed device complaints (returned and no product returned) from october 2021 - september 2022 for the sapien m3 valve (all models and sizes) was performed with the codes identified below.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.Of the root causes identified, the procedural factors (under-expanded valve) is potentially applicable to the complaint.Ifu sapien m3 system and procedural manual were reviewed.No ifu/training 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 central leak and stenosis were confirmed from the medical record.A review of dhr, lot history and complaint history did not provide any indication that manufacturing non-conformance contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien m3 valves are 100% visually inspected for defects and 100% functionally 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.As reported, ''tte performed on pod 1 revealed the bioprosthetic valve in mitral position was well placed with no significant perivalvular mr.Mild mitral valve regurgitation was noted along with a mean gradient of 8-14 mmhg.During the patient's 30 day follow up visit tee performed (10/14/2022) shows severe stenosis with a mean gradient of 11mmhg.Per the records received, the mitral bioprosthetic valve is well-seated.Mild transvalvular regurgitation.Severe stenosis with a mean gradient of 11 mmhg.Mv lvot vti 23.2 cm''.Per echo core lab assessment, on pod-1 and on 30-day follow up tte, transvalvular mitral regurgitation degree was trace, and there were no intracardiac thrombus, mass, or vegetation was present.Per the instructions for use (ifu), valve regurgitation is a known potential adverse event associated with bioprosthetic heart valves and the procedure.Per medical records, there was trace mv prosthetic regurgitation noted post-procedure.Mild mv prosthetic regurgitation with mean gradient of 8-14mmhg was noted on pod-1.On pod-30, the implant remains well seated with mild mitral regurgitation and mean gradient of 11mmhg.Regurgitation post-procedure can be due to sub-optimal coaptation of the valve leaflet.Per procedural imagery, a waist was present on the deployed valve.Thv must be fully deployed for proper function; under-deployed valve may affect leaflet motion, resulting in central regurgitation.Similarly, valve stenosis, which was noted on pod-30, can also impact leaflet coaptation leading to the same failure.However, there were no reports or corelab assessment of reduced leaflet mobility on pod-1, and leaflets were assessed to be freely mobile per corelab assessment on pod-30.Without further information, a definitive root cause was unable to be determined at this time.In this case, valve area was not provided.Due to limited information, a definitive root cause is unable to be determined at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.No corrective or preventative actions are required.

Manufacturer Narrative

An update was received from the study site indicating that during the patient's 6 month follow up visit the mean gradient across the valve had increased from 11mmhg to 13mmhg.There was no mention of any intervention.

• Brand Name: SAPIEN M3 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: 15811220
• MDR Text Key: 303794343
• Report Number: 2015691-2022-09281
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 9880TFX29MCLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Male