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

Model Number 11400M

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

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 medical records review that a 25mm 11400m mitral valve exhibited immobile leaflets after an implant duration of four days.Per medical records, underwent redo mvr.On pod #3, tee revealed likely thrombus formation on the prosthetic mitral valve.On pod #4, the patient was taken to the or for ramp study.Tee revealed that two of the leaflets appeared immobile on the mitral prosthetic valve, which were frozen with almost a new fusion of the commissure.Therefore, an attempt was made to free them up by accessing the left atrium and passing a wire into the ventricle.The wire appeared to fall into the frozen commissure and opened it up and the valve began to function; therefore, further manipulation was abandoned.The initial intention was to perform a balloon valvuloplasty.

Event Description

It was learned through medical records review that a 25mm 11400m mitral valve exhibited immobile leaflets after an implant duration of four days.Per medical records, underwent redo mvr.On pod #4, returned to or for mediastinal exploration and washout, and ramp study.Mitral valve tee showed two of the leaflets appeared immobile, frozen with almost a new fusion of the commissure.Balloon valvuloplasty was attempted, however while passing glidewire across the valve it fell into the frozen commissure and opened it up, the valve then began to function.The patient was returned to the ct-icu in critical condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections h6 (type of investigation, investigation findings, investigation conclusions).Leaflet immobility or leaflet restriction occurring during early post-operative period can be attributed to non-structural valve dysfunction (nsvd), which can be manifested as regurgitation and/or stenosis.Nsvd is any abnormality that is not intrinsic to the valve itself or do not directly involve valve components, yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.Additionally, leaflet restriction can also be caused by chordae entrapment when subvalvular apparatus sparing technique is utilized.It was reported that the patient was bleeding post-procedurally and was placed on iabp and ecmo.These might have contributed to formation of clots or thrombus or decreased hemodynamic pressure across the valve likely leading to 'immobile, frozen leaflets'.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.The subject device is not available for evaluation as it remains implanted in the patient.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.H10: corrected data: corrected section 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: 18400047
• MDR Text Key: 331413278
• Report Number: 2015691-2023-18781
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)270620(11)230621
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: 55 YR
• Patient Sex: Female