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

Model Number	11400M
Medical Device Problem Codes	Gradient Increase (1270); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it remains implanted in the patient.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 or Problem Description
It was reported that a patient with a 25mm 11400m mitral valve has been placed under evaluation/consideration for a valve-in-valve procedure after an implant duration of 3 months due to unknown reason.Gradient on echo is 9-10 mm hg.The physician said that it has been the same since implant and wondered about patient prosthesis mismatch.Although, this was the largest size he could get in.The physician was thinking to use beta blockers to slow down patient's heart rate, but they plan to do a mviv ct as well.Based on the echo-based gradients and the unchanged gradients, this does not meet the varc3 definition of structural valve deterioration.
Additional Manufacturer Narrative
Component code, device code, type of investigation, investigation findings).Engineering evaluation summary: high gradients can occur early or late in the lifetime of a prosthetic valve.When it occurs early after valve replacement, it is typically a result of pressure recovery, patient-prosthesis mismatch, and/or subvalvular or supravalvular obstruction.Measurement error, a high-flow state, prosthesis dysfunction, and pannus overgrowth can cause late high gradients after aortic valve replacement.Prosthesis dysfunction is most likely related to patient/procedural factors, and not to manufacturing non-conformances, which most likely would be identified intraoperatively or early post implant.A definitive root cause cannot be conclusively determined; however, procedural factors likely caused or contributed, including the possibility of patient prosthesis mismatch as reported by the surgeon.All pertinent information available to edwards lifesciences has been submitted.
Event or Problem Description
It was reported that a patient with a 25mm 11400m mitral valve has been placed under evaluation/consideration for a valve-in-valve procedure after an implant duration of 3 months due to increased gradient.The plan is to follow up with a mviv ct.Per information received the gradient on echo is 9-10mmhg.The gradient has remained at 9-10mmhg since implant.The surgeon mentioned the 25mm 11400m was the largest valve they were able to implant and that ppm is a possibility.Based on the echo-based gradients and the unchanged gradients, this does not meet the varc3 definition of structural valve deterioration.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).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.Engineering evaluation summary: per drm doc-0105049, rev d, patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.A definitive root cause cannot be conclusively determined; however, procedural factors likely caused or contributed.Despite repeated attempts to obtain further information regarding this event, no additional information has been received from the customer at this time.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17244356
• Report Number: 2015691-2023-14334
• Device Sequence Number: 5260026
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)240203(11)220203218664882
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 11400M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 08/23/2023
• Initial Report FDA Received Date: 07/01/2023
• Supplement Report FDA Received Date: 08/22/2023; 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 78 YR
• Patient Sex: Male