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

Model Number	11400M
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information are in process; 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 or Problem Description
Per the report received from south korea, a 11400m25 valve implanted in the mitral position was explanted after an implant duration of four (4) days.The implantation was initially reported as successful.Intraoperatively, the surgeon double checked the valve's function and all three leaflets open and close well during visual inspection.During immediate intra-operative echocardiography, there was minimal unusual mitral regurgitation, and the valve motion appeared normal.However, over the following four (4) days, gradual abnormal function was detected.Echocardiography diagnosed that two leaflets of the valve had become immobile.Consequently, a decision was made to explant the 11400m25 valve and proceed with reoperation.According to the scrub nurse present during the explant, there was no evidence of suture looping.A 27mm non-edwards valve was implanted in replacement.The patient was discharged under a safe health condition.
Additional Manufacturer Narrative
Added information to section b5 (description of event), d9 (device availability), h2, h3 and h6 (type of investigation).Corrected data in section d4 (expiration date) and d4 (primary udi number).H11.Additional narrative/data: the device history record (dhr) 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 device was returned for evaluation.Customer report of "gradual abnormal function" was unable to be confirmed as per condition of return.As received, all three leaflets were stiff and translucent-like due to dehydration.X-ray demonstrated wire form intact.Multiple suture holes were visible around the sewing ring.Sewing ring cloth was cut in multiple areas around the valve.No other visible inconsistencies were observed on the valve.Returned unit appeared consistent with customer provided pictures; however valve appeared not dehydrated in the pictures.Functional testing cannot be performed due to the valve condition as received.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
Per the report received from south korea, a 11400m25 valve implanted in the mitral position was explanted after an implant duration of four (4) days.The implantation was initially reported as successful.Intraoperatively, the surgeon double checked the valve's function and all three leaflets open and close well during visual inspection.During immediate intra-operative echocardiography, there was slightly high pressure detected, and the valve motion appeared normal.However, over the following four (4) days, gradual abnormal function was detected.Echocardiography diagnosed that two leaflets of the valve had become immobile and the mitral valve area was very narrowed (peak gradient 35mmhg / mean gradient 20 mmhg and mitral valve area (mva) of 1.0 cm2).Consequently, a decision was made to explant the 11400m25 valve and proceed with reoperation.According to the scrub nurse present during the explant, there was no evidence of suture looping.A 27mm non-edwards valve was implanted in replacement.The patient was discharged on post-operative day (pod) 16 and was in stable condition.
Additional Manufacturer Narrative
Added information to section h6 (investigation findings) and h6 (investigations conclusions).H11: additional manufacturer narrative: the subject device passed in-process inspections for flow and coaptation, as well as visual inspection for cusp symmetry, valve circularity, and leaflet coaptation quality.Based on the information available, the complaint of "two leaflets of the valve had become immobile and the mitral valve area was very narrowed" was unable to be confirmed.Through evaluation of returned device, creases were observed on the leaflets.Leaflet creasing was found on the outflow side of leaflet 3 near commissure 1 and on the inflow side of leaflet 1 near commissure 2.Prolonged dehydration and then subsequent formalin storage can cause the valve leaflets to shrink and set the leaflets in a fixed position, creating improper coaptation of the leaflets.Leaflet creasing is caused from a force being applied to the leaflets, which is made more pronounced by excessive dehydration and then subsequent storage in formalin.For this event a definitive root cause cannot be conclusively determined; however, there is evidence of leaflet creasing prior to product dehydration, which could have been caused due to a retrograde force applied to the leaflet and contributed to the reported leaflet immobility/restricted motion.An edwards defect has not been confirmed.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: 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; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20501302
• Report Number: 2015691-2024-07990
• Device Sequence Number: 7629419
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)260216(11)220217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Model Number: 11400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 12/10/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/20/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male