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

Model Number	11060A
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Chest Pain (1776); Insufficient Information (4580)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: attempts have been made to obtain product for evaluation.No device was returned.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 implant patient registry and investigation that a 29mm 11060a aortic valve was explanted after an implant duration of four (4) years, and nine (9) months due to unknown reason.The explanted valve was replaced with a 25mm 11060a aortic valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11: additional narrative updated h6 dehiscence refers to the separation of the prosthetic valve from the surrounding heart tissue, typically at the sewing ring where the valve is sutured to the annulus.This separation can cause blood to leak around the valve (paravalvular regurgitation), reducing its effectiveness and straining the heart.This generally occurs due to patient-related anatomical factors, such as irregular anatomy, which may lead to increased stress on the surrounding tissue over time.This is often as a result of successive dilation of cardiac structures caused by progressions of valvular disease.Paravalvular/perivalvular leak (pvl) refers to blood flowing through a channel between the sewing ring of the implanted valve and the cardiac tissue due to an insufficient seal of the valve to the annulus.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl, as the bioprosthesis may not seat properly after debridement.Technique related factors during implantation, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may also create difficulty seating the bioprosthetic valve, resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including pseudoaneurysm, htn, hld, obesity and heart failure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections b5, b7, g3, g6, h2, h6 (health effect - clinical code, device code(s), type of investigation).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 implant patient registry and investigation that a 29 mm 11060a aortic valve was explanted after an implant duration of four (4) years, and nine (9) months due to ascending aortic aneurysm with dehiscence on the aortic root and paravalvular leak.The explanted valve was replaced with a 25 mm 11060a aortic valve.Per medical records, the patient presented chest pain.Intraoperative findings showed severe aortic insufficiency with a paravalvular/para root leak into a pseudoaneurysm with flow back into the graft.The patient also had dehiscence aortic root prosthesis at the aortomitral curtain.The patient was transferred to icu.

• 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 reeves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24553373
• Report Number: 2015691-2026-13070
• Device Sequence Number: 5597450
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)220401
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 04/01/2022
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male