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

Model Number	11060A29
Medical Device Problem Codes	Perivalvular Leak (1457); Separation Failure (2547)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Insufficient Information (4580)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
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 events.Trends are monitored on a the investigation is still in progress; therefore, a conclusion has yet to be established.
Event or Problem Description
It was reported that a patient with a 29mm 11500a aortic valve underwent a valve-in-valve procedure after an unknown implant duration due to dehiscence and severe pvl.Two 29mm 9755rsl transcatheter valves were placed to seal the pvl through stent cage.
Additional Manufacturer Narrative
Added information to b5, d1, d2, d4, d6, h4.Corrected model and serial number based on additional information received.
Event or Problem Description
It was reported that a patient with a 29mm 11060a aortic valved conduit underwent a valve-in-valve procedure after implant duration of 3 (three) months, due to dehiscence and severe pvl.Patient presented with heart failure.Two 29mm 9755rsl transcatheter valves were placed to seal the pvl through stent cage.Patient was in stable condition and has been discharged.
Event or Problem Description
It was reported and learned through medical records a patient with a 29mm 11060a aortic valved conduit underwent a valve-in-valve procedure after implant duration of 3 (three) months, due to severe pvl resulting in pseudoaneurysm.Two 29mm 9755rsl transcatheter valves were implanted with one week apart.The patient left in hemodynamically stable condition.Patient was discharged on pod # 21.Per medical records, the patient is s/p modified bentall procedure which was complicated by cva.Ct scan demonstrated aortic pseudoaneurysm from a paravalvular/paraconduit leak.The patient had another embolic event during his hospital stay.Per surgeon, this pseudoaneurysm presumably caused those embolic events.The risk for redo surgery was prohibitively high, therefore, he underwent a transcatheter aortic valve in valve replacement with small residual leak.A week after the viv procedure, it appeared that the valve may have been too deep resulting in severe valve stenosis and required a second transcatheter valve (valve-in-valve-in-valve).The patient tolerated the second viv procedure well, will be taken to the intensive care unit.
Additional Manufacturer Narrative
Added information to b5, b6, b7, h6.The device history record (dhr) review was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is insufficient information available regarding patient or procedural factors known to cause or contribute to pvl.Therefore, a definitive root cause cannot be conclusively determined.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23240962
• Report Number: 2015691-2025-08187
• Device Sequence Number: 8588119
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406
• 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: 2025
• 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): 11/27/2025

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: 11060A29
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 11/14/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/26/2025
• Date Device Manufactured: 02/03/2025
• 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: 59 YR
• Patient Sex: Male