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); Insufficient Information (4580)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and 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

Through implant patient registry it was learned a 31mm 11400m mitral valve was explanted after eight (8) months, due to unknown reasons.The explanted device was replaced with a 29mm 11400m mitral valve.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

Added information to b5, b7, h6.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Event Description

Through implant patient registry and investigation, it was learned a 31mm 11400m mitral valve post implant developed pvl and dehiscence secondary to prosthetic valve endocarditis.The valve was explanted after eight (8) months and ten (10 days) and replaced with a 29mm 11400m mitral valve.Per medical records, the patient initially had mssa endocarditis of native tricuspid and mitral valves and underwent mitral valve replacement and tricuspid valve repair (4900 ring) due to iv drug abuse.The patient was admitted and discharged approximately five (5) months post implant with a relapse in iv current drug use and diagnosed with mssa endocarditis and a large mass in the bioprosthetic tissue valve.The patient presented 3 months later with a large paravalvular leak causing severe mitral regurgitation with dehiscence.The patient underwent redo mvr.Intraoperatively there was no evidence of endocarditis, there was mitral valve dehiscence from the annulus with near complete separation and likely burned area of paravalvular abscess.After meticulous debridement, a 29mm 11400 valve was implanted.Post procedure tee confirmed excellent mitral valve function with no mr or residual pvl.There was no evidence of endocarditis on the tricuspid or aortic valves.After weaning from bypass there was moderate tricuspid regurgitation, due to potential hypertension, the decision was made to leave the tricuspid valve alone.The patient tolerated the procedure well and was transferred to the icu in stable condition.

• 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: 18056453
• MDR Text Key: 327177527
• Report Number: 2015691-2023-17197
• Device Sequence Number: 1
• Product Code: LWR
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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: 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: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female