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 Interaction Problem (4001)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
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 learned through medical records that a patient with a 23mm 11060a aortic valved conduit underwent percutaneous intervention due to coronary obstruction.The patient was taken to the icu in stable condition post procedure.Per medical records, the patient was asymptomatic upon presentation.Tte ((b)(6) 2025) revealed severe bioprosthetic aortic stenosis with ef of 55-60%.Redo sternotomy was performed to explant the previous 23mm manga aortic valve (b)(4).The previous valve was explanted and the area was debrided.The surgeon went to place a 23mm inspiris valve but found that the left main coronary ostium was obstructed by the sewing ring.This prompted the surgeon to remove the 23mm inspiris and replace the aortic root with a 23mm konect valved conduit instead (b)(4).Once off bypass, there was mild to moderate rv dysfunction.Prior to leaving the or, the patient developed ventricular fibrillation on several occasions and was defibrillated each time successfully.The surgeon had a concern about the integrity of the patient's right coronary artery.The patient was taken to the cath lab for cardiac catheterization where the patient's right coronary artery was stented and flow was restored.The patient was taken to the icu in stable condition post procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections h6 (investigation findings, investigation conclusions).The complaint is unable to be confirmed as there was no product available for evaluation and no relevant imagery provided.There is no evidence to suggest an edwards/supplier manufacturing defect.Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement.It is typically the result of a technical error during valve implant and not related to a device malfunction.The instructions for use (ifu) 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.A dhr review was performed, and no related manufacturing nonconformances were identified.In this case, its likely that the patient annulus was altered after the first two valves were explanted before the konect valved conduit.These anatomical constraints combined with an additional surgery for the konect can cause obstruction.The most likely cause is procedural factors including the patient's previous surgeries.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).

• 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: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23316351
• Report Number: 2015691-2025-08552
• Device Sequence Number: 20284242
• Product Code: LWR
• UDI-Device Identifier: 00690103201383
• UDI-Public: (01)00690103201383(17)270123
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 09/26/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female