MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Thrombosis/Thrombus (4440)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported a patient with a 27mm 11400m mitral valve implanted one (1) year, (1) month, is planned for tmvr due to surgical valve failure.It was found that the patient had an area of thrombus along a quarter of the corknots anchoring the valve.The tmvr case was discontinued so the team could address the thrombus.Patient was returned to his room without any intervention and no edwards products used to treat the patient.This 50-year-old male patient has a history of hypertension, hyperlipidemia, diabetes, sleep apnea, end stage renal disease - on dialysis, dual chamber pacemaker, avr/mvr/tvr ((b)(6) 2022).A patient with a 25mm 11500a aortic valve ((b)(4)) implanted one (1) year, one (1) month, was reported to have mild perivalvular leak.No intervention has been indicated or planned.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The most likely cause of the event was due to patient factors/conditions.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

It was reported and learned through investigation that a patient with a 27mm 11400m mitral valve implanted one (1) year, (1) month, developed mrsa endocarditis with thrombus.Patient is being treated with iv antibiotics with plans for redo mvr.It was initially reported that the patient underwent attempted viv due to severe stenosis.Annular thrombus along a quarter of the cor knots anchoring the valve was found and the procedure was aborted.The patient was transferred to the icu to address the thrombus.Per medical records, a month prior to attempted viv, outpatient echo showed thrombus on the mitral leaflet, the patient was transition from eliquis to warfarin.Plan is now for redo smvr but was postponed due to mrsa bacteremia.Doctors are highly concerned that he may have been bacteremia for weeks now and that his malfunctioning valve is indicative of endocarditis.Suspect use of his av fistula introduced the bacteremia (although fistula appears not to be infected) no other obvious sites, will continue to monitor.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18342227
• MDR Text Key: 330664059
• Report Number: 2015691-2023-18453
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)240420(11)220421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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 Expiration Date: 04/20/2024
• Device Model Number: 11400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/17/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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; Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male