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

Model Number	11060A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections h6 (investigation findings, investigation conclusions).Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event was determined to be due to patient related factors.The stenosis in this case was impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.H11: corrected data: corrected section h6 (type of investigation).
Additional Manufacturer Narrative
H11: 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 or Problem Description
It was reported and learned through medical records that a patient with a 29mm 11060a aortic valved conduit underwent a valve-in-valve procedure after an implant duration of 4 years, 1 month due to severe stenosis.The patient presented with heart failure, sob, and cardiogenic shock.The procedure was performed with a 29mm 9755rsl transcatheter valve.The patient was discharged pod #8.Per medical records, the patient presented with cardiogenic shock in the setting of nyha class iv heart failure and nstemi.Tavr procedure was performed to disable the 29mm valved conduit and implant a 29mm sur.The patient was discharged pod #8.It was noted that the patient has an esrd and is currently on hemodialysis.

• 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; CA
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24214539
• Report Number: 2015691-2026-10646
• Device Sequence Number: 20930754
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)230707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 03/02/2026

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 Expiration Date: 07/07/2023
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2021
• 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: 52 YR
• Patient Sex: Male