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

Model Number	11400M25
Medical Device Problem Codes	Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional narrative surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was discarded.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that a 11400m 25mm mitral valve was explanted at implant because the posterior lateral stent possibly caused a hole in the epicardium that led to bleeding at the base of the left atrium.A non-edwards valve was implanted in replacement.As reported the surgeon felt the posts are shorter and potentially less traumatic, and a perceval.The surgeon also noted the tissue quality of the patient was less than he expected.
Event or Problem Description
It was reported that a 11400m 25mm mitral valve was explanted at implant because the anterolateral stent post possibly caused a hole in the left ventricular wall, leading to bleeding at the base of the left atrium.A non-edwards valve was implanted in replacement.As reported, surgeon noted the tissue quality of the patient was less than he expected.Post-bypass echo after coming off cpb initially reveals probable severe mr in large pvl with jet origin posterior to the sewing ring extending to at least 25% of the circumference of the bioprosthesis.Bleeding was noted at the base of the left atrium and the 25mm 11400m mitral valve is explanted.Concomitantly, the patient had underwent avr with an inspiris valve.Echo report shows aortic valve bioprosthesis with no ar and normal leaflet motion/appearance.The aortic valve had to be explanted at implant for better visualization and repair of the bleeding.After difficult repair, the surgeon opted to implant a non-edwards valve as the surgeon felt the posts were shorter and potentially less traumatic.
Additional Manufacturer Narrative
H11.Additional narrative.Updated b5 and h6.
Additional Manufacturer Narrative
Based on the information available, the most likely cause is procedural factors.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were 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.

• Brand Name: EDWARDS 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20217147
• Report Number: 2015691-2024-07108
• Device Sequence Number: 7328571
• Product Code: LWR
• UDI-Device Identifier: 00690103205534
• UDI-Public: (01)00690103205534(17)271129(11)231130
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Model Number: 11400M25
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 10/21/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/17/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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 Sex: Unknown