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

Model Number 11400M

Device Problems Fluid/Blood Leak (1250); Central Regurgitation (4068)

Patient Problems Myocardial Hypertrophy (4447); Insufficient Information (4580)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: 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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned through implant patient registry that a 27mm 11400m mitral valve exhibited severe insufficiency after an implant duration of 8 months.The patient underwent a heart transplant and the mitral bioprosthetic was removed along with the native heart.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections h6 (component code, health effect - clinical code, type of investigation, investigation findings, investigation conclusions).Mitral regurgitation (mr) in bioprosthetic heart valves occurs when the valve does not close properly in systolic phase, which results in retrograde flow of blood into the left atrium.However, if the regurgitation worsens or becomes symptomatic, reoperation may be necessary.Technique related issue is valve distortion during implant which may result in a dropped leaflet or asymmetric coaptation.[this technique is] not typically the result of product malfunction; however, they may contribute to mild to severe regurgitation and if undetected may require reoperation.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.The most common reason for bioprosthesis explant encompasses multiple failure modes which can lead to chronic central leaks over a period of time.Such failure modes may occur singularly or concomitantly which may interfere with functionality of the device.Although the subject valve showed severe regurgitation after an implant duration of 8 months, the patient requiring a heart transplant likely indicates that pre-existing patient factors likely caused early valve failure requiring a reintervention post-operatively, in addition to history of atherosclerosis and cabg.Based on the information received, the complaint of regurgitation is confirmed.A root cause of the valve failure could not be determined; however, patient factors likely caused or contributed.An edwards defect has not been confirmed.The subject device is not available for evaluation as it was discarded.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.H10: corrected data: corrected sections b7 as it was blank and should have read "mvr and avr (3/29/23) severe calcific atherosclerosis coronary arteries s/p stent and cabg, and myocardium hypertrophy" on the initial fda report, h6 (device code).

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18581736
• MDR Text Key: 333745485
• Report Number: 2015691-2024-00588
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)240914(11)220915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048/S047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female