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

Model Number 9880TFX29MCLUS

Device Problems Restricted Flow rate (1248); Difficult to Open or Close (2921)

Patient Problem Dyspnea (1816)

Event Date 11/12/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device is not available for evaluation as it remains implanted in the patient.

Event Description

As reported through the encircle clinical trial, the patient presented to the er with dyspnea.A tee was performed in the er which showed abnormal rocking of the prosthetic mitral valve suggests dehiscence, and the patient was hospitalized for further evaluation.A tee was then done which showed that the m3 valve exhibited restricted leaflet motion, a mean gradient of 3 mmhg, mild pvl (medially and laterally), and there was a significant amount of spontaneous contrast noted in the left atrial appendage.The patient was prescribed anticoagulation medication and discharged 2 days after admission.Per review of the medical records, tte performed while in the emergency room showed a sapien m3 valve in the mitral position.The mean gradient is 3.The prosthetic mitral valve appears to open well.There is abnormal rocking of the prosthetic mitral valves to suggest dehiscence.There is mild pvl noted.It is difficult to accurately assess the degree of mitral regurgitation due to an eccentric jet and shadowing from the device.Per the discharge summary, the patient was admitted with symptoms of shortness of breath that had been on and off with some worsening.An echo was done in the emergency room that showed possible increased rocking of the mitral valve and the patient was admitted for further evaluation.Tee showed reduced left ventricular systolic function.There is restricted prosthetic mitral leaflet with a mean gradient of 3 mmhg.There is mild paravalvular leaks noted medially and laterally.Significant amount of spontaneous contrast noted in the left atrial appendage.The patient was prescribed anticoagulation medication and discharged 2 days after admission.

Manufacturer Narrative

Corrected b.5 after image review and review of imagery for the reported event.Per an internal imaging review by the implanting edwards sonographer, comparing imaging from the time of the procedure to imaging received for this event, the dock height at the time of deployment was on the lower end but within acceptable limits.There was no mitral valve dehiscence.There have been no interval changes since the implant.The motion of the sm3 valve on the anterior side was noticed at the time of implant and is due to the height of the dock deployment.As the sm3 valve sits within the m3 dock, the motion observed is due to the height of the dock deployment.As such, any abnormal motion visualized on the valve is due to the dock, not the valve.H.6 type of investigation, investigation findings, and investigation conclusions have been corrected based on engineering evaluation.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 valve - model 9600tfx29).The pma/510k field was left blank in the initial mdr for this reason.The serial number is (b)(6).The valve was not returned for evaluation.A device history review (dhr ) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed one event of motion restricted valve leaflet.That event was still undergoing engineering evaluation.During manufacturing of the sapien m3 valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.Imagery was received and reviewed.Tte showed the m3 leaflet closest to the aortic valve appeared to be restricted/not moving and there was either thrombus/sludge or soon to be thrombus in the left atrial appendage.Tee noted persistent, significantly restricted movement of the leaflet.Significant uniform thickening was observed.Based on the imagery review the motion restricted valve leaflet was confirmed.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.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.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defects were identified, no corrective or preventative actions are required.The motion restricted leaflet was confirmed based on imagery provided for evaluation.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials 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, ''tee shows restricted prosthetic mitral leaflet'' and ''eliquis stopped.Coumadin started with lovenox bridge.'' per tee, ''left ventricular systolic function is severely reduced.'' there are several factors that could result in restricted leaflet motion such as under-expanded valve, improper management of antiplatelet therapy (thrombus formation), patient physiology (e.G., blood chemistry) results in halt/ham on valve leaflets.Per the medical record, anticoagulant medication was changed potentially due to suboptimal anticoagulation therapy or suspicion of thrombus.Per imagery review, leaflet with restricted motion was observed to be significantly thickened, and thrombus was observed in the left atrial appendage.Leaflet thickening can impact leaflet mobility/ functionality and leaflet coaptation.Additionally, a reduced left ventricular systolic function could also impact leaflet coaptation and mobility.As such, available information suggests that patient factors (leaflet thickening, reduced left ventricular systolic function) may have contributed to the complaint event.

Event Description

As reported through the encircle clinical trial, the site reported that the patient went to the er for shortness of breath.A tte was completed which showed ''abnormal rocking of the prosthetic mitral valve suggests dehiscence,'' however, an imaging review confirmed that there was no valve dehiscence, and the ''rocking'' was related to the dock, not the valve.There was also a restricted prosthetic mitral leaflet with a mean gradient of 3 mmhg.The patient was prescribed anticoagulation medication and discharged 2 days after admission.

• Brand Name: SAPIEN M3 VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15946814
• MDR Text Key: 305142741
• Report Number: 2015691-2022-09763
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103214291
• UDI-Public: (01)00690103214291(17)240329
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 02/13/2023
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female