MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	11060A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	11/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 learned through medical records received that after implant of a 23mm 11060a aortic valved conduit (avc), there was severe native mitral valve regurgitation.The native mitral valve was replaced with a 25mm mitris valve.The patient underwent a redo avr for endocarditis.A 23mm 11060a avc was implanted in replacement and the valve itself seated well.While weaning from bypass it became apparent the native mitral valve was severely regurgitant, likely secondary to anterior leaflet of the annulus was restricted or foreshortened as part of the implantation of the avc in the lvot.The decision was made to replace the mitral valve, transseptal approach was used but still difficulty visualizing the anterior leaflet.A 25mm mitris valve was implanted with pledgeted sutures and secured with cor-knots.Post cpb tee showed 23mm avc and the 25mm mitris valve well-seated with normal function and no pvl.While weaning from bypass there was extensive bleeding from the proximal end of the aortic root replacement suture line.Despite attempts to gain hemostasis, the hemorrhage was unsurvivable.The decision was made to stop further resuscitation and the patient expired in the or.
Additional Manufacturer Narrative
Updated section b4.Updated sections g3, g6.Updated sections h2, h6, type of investigation; investigation findings; investigation conclusions.H11: additional manufacturer narrative: the reported complaint is unable to be confirmed.Based on the information available, the most likely cause is procedural factors, likely secondary to anterior leaflet of the annulus was restricted or foreshortened as part of the implantation of the avc in the lvot.The (ifu) instructions for use have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The reported type of event is included in the ifu.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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: 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: jason reves ; 1 edwards way; mle fl2; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24226224
• Report Number: 2015691-2026-10698
• Device Sequence Number: 9238283
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)280803
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 11060A
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male